Freestyle Libre Failures


#101

Everytime I insert a new Libre sensor, I test it’s accuracy with my glucose meter. The first 2 - 3 hours will be suspect as the sensor gets acclimatized to the new site. I usually insert the new sensor 2-3 hours before I activate it. When the old sensor alarms with 3 hours left, I insert the new one. When the old one dies, I start the new one. But still, its readings will not be very accurate at the start. Just the nature of the beast.

ALSO I KNOW THAT THE COMPARISON WITH THE METER AT VERY HIGH AND LOWS WILL NOT BE ACCURATE, ALSO WHEN THE TREND ARROW IS NOT FLAT. DO NOT COMPARE WITH METER WHEN THE ARROW IS NOT FLAT. REMEMBER METERS ARE ALLOWED BY FDA REGULATION TO BE ONLY 15% ACCURATE 95% OF THE TIME. ALSO REMEMBER, THE LIBRE READING IS TYPICALLY 10-15 MINUTES AFTER THE METER READING. REMEMBER THIS WHEN COMPARING READINGS.

EXAMPLE, A TRUE BLOOD READING OF 100 CAN BE REPORTED BY THE METER AS 85 TO 115 AND STILL BE FDA ACCURATE. SO, WHO DO YOU REALLY BELIEVE, YOUR CGM OR YOUR METER?

REALITY SUCKS SOMETIMES.


#102

I would be ecstatic with 15 points - it is off 40 or more too many times


#103

That sucks. Have you used dexcom and/or enlites? The other systems have calibration abilities. Libre does not. I believe, limiting the site to the upper arm has something to do with it. I put my sensor on my leg once and it read consistently 40-50 lower. I then just put it on my upper arm. I am usually within 10 with the meter.


#104

Been down the enlight road - a total horror story - My opinion is that it was and is mass consumer fraud on the community which can least stand it - then medtronic overbilled me and that took over a year to resolve - they lied to me for a year until I threatened to go to the atty general to resolve it - all the while hounding me for the money. Medtronic actually asked to prove correspondence they sent. How do I do that? Build a time machine and go back in time to watch them send it. If my life depended on doing business with medtronic I would choose death.

There is a PDF of the Libre sensors showing results on the stomach area verses the arm - it does better on the arm.


#105

Well said. After my first week my meter has much more often than not, matched the sensor. And yesterday they decided to accept a pre auth at the pharmacy and my price is now fantastic! My numbers btw, have been consistent with my meter in both high and low comparisons. My CDE said to be doing finger sticks if you question things, but then again that may not be the info everyone is getting . However, is there not a feature built in to the meter that says to go use a finger stick on occasion? I love my Libre, and am blessed to have it.


#106

Another experience with the Libre… I use my upper arms for infusion set sites. I had it close to the Libre sensor, and I noticed the Libre readings were lower than the meter, say 20-40 lower. After realizing that, I never put the infusion set near the Libre sensor and my readings are then good.


#107

I just checked the Freestyle Libre System In-Service Guide. The very first page includes a list of warnings about depending on the system for treatment decisions. Basically, it says that if your symptoms are different than the displayed reading then you should confirm any decision with a fingerstick.

I think if the FDA insisted on absolute accuracy 100% of the time, we would be waiting an awful long time to use this technology. I’ve never used a Libre but I have used CGMs for nine years now. Even though the readings are not 100% dependable, I find this technology adds an immeasurable amount to my quality of life. I consider it one of the most valuable technologies in my 34 years of living with T1D. My life is much better with CGM-tech than it would be without it.


#108

Remember this? How can we complain with the existing technology?
How about talking glucometer. Bluetooth glucometer. Artificial Intelligent glucomer/CGM.


#109

THIS IS THE BEST GLUCOMETER/CGM. RIGHT? DAD!

DAD-patch-on-dog-cropped1


#110

I use a hypoglycemia alert dog, too. Sometimes people ask me why I need a dog if I also use fingersticks and a CGM. I answer that the best safety systems use multiple redundant data sources. I have had all systems fail me at the same time but that is relatively rare.


#111

I have an entire Freestyle Libre kit and 3 sensors unopened and sitting on my dining room table…I have not contacted my friend at the FDA…YET!..I’ve decided to do a little experiment using my Medtronic CGM and the Libre…I want to see just how “off” they are from each other “TREND WISE”…as this is what I prefer to go by and not the number itself…when making my treatment decisions…If these are way off as well as the actual numbers then I WILL be contacting my friend and filing a complaint and will make it my lifes work to get the Libre of the shelf before someone gets hurt or worse from using it to dose off of.


#112

Patients, healthcare professionals and consumers who find a problem related to a medical device are encouraged to report medical device adverse events or product problems to FDA …

https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM163919.pdf

Each year, the FDA receives several hundred thousand medical device reports of suspected device-associated deaths, serious injuries and malfunctions. Medical Device Reporting (MDR) is one of the postmarket surveillance tools the FDA uses to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products.

Mandatory reporters (i.e., manufacturers, device user facilities, and importers) are required to submit certain types of reports for adverse events and product problems to the FDA about medical devices. In addition, the FDA also encourages health care professionals, patients, caregivers and consumers to submit voluntary reports about serious adverse events that may be associated with a medical device, as well as use errors, product quality issues, and therapeutic failures. These reports, along with data from other sources, can provide critical information that helps improve patient safety.


#113

Please stop threatening to “get the Libre off the shelf”. While it may not work for everyone, for some of us it is the only affordable option for a CGM and for me personally they work very well and I have very few complaints. It is only approved for use in adults in the US so if you are not responsible enough to use any CGM numbers with caution then maybe you should just not use this very helpful and affordable tool.

This device has saved me almost 1500 finger sticks in the last 4 months and if your vendetta gets the Libre taken off the market then my health and well being will suffer. Btw, I have only had one funky sensor and even then I was not harmed by it because I knew the readings were not right so I didn’t blindly trust what it was saying.

The packaging says that if you experience symptoms that do not match your readings then you must do a blood test to confirm and my Libre will sometimes alert that there may be an issue with the reading so I do not make a treatment decision off of that reading. This is not a mindless device and it was not meant to be.

This device may be new to the US but it has actually been around for several years so it is not the newest most accurate product on the market. If you want a CGM that you can use mindlessly (supposedly) then get a Dexcom G6 when it comes out in a few months, but I still wouldn’t rely completely on any current technology to take care of me because ultimately it will still be my responsibility to take care of myself.


#114

Relax - Libre is not going to come off the market - period

The No Fingerstick claim should be altered

Great it works for you

It works a little for my wife and has helped but is not reliable enough to save ANY FINGERSTICKS


#115

Right on, @Firenza! This whole issue of accuracy seems a bit overblown. Looking back at the BS meters of my last 40 years, most would be inaccurate by today’s standards. But I used them and they helped me improve diabetes control. Many of the BS meters on the market today are inaccurate to some degree. So any call to get the Libre “off the shelf” should include a call to get all those meters off the shelf too. None of these are mindless tools. If a particular one isn’t working for you — stop doing that!

Also, the accuracy of a meter or CGM is only part of the equation. Food producers are permitted a+/- error of 20% in labeling according to Dr Bernstein. So even with an absolutely accurate meter or CGM, perfect blood sugars are not assured. Add in day to day variabilities in how our bodies react, exercise, Dawn phenomenon, etc. and its amazing how well we do.

For me, the question is always, “does this particular tool improve my control?” If the answer is “yes,” I’m going to use it regardless of its lab accuracy or what others think. For me the Libre gets a definite “yes.”


#116

Ditto what Firenza said. I’m a member of a wonderful online group for USA users of the system, and they are for the most part thrilled and doing fine. There are probably more patients who have suffered from malfunctioning pumps, than from the Libre.


#117

Boy it’s matching two of my meters within a few digits, Second sensor…:slight_smile:


#118

Who wants a world where you can have any car as long as it is a Black Ford.

Choice is nice.

If somebody has an adverse event then report it if you feel it appropriate. Take advantage of your choices and try something else. Move on. Don’t get stuck with what does not work for you. Find what does work for you.


#119

Update; I have been using the FreeStyle Libre Sensors for 3 months now. I do have to say I love them when they work. I have found about 1 out of every 3 seem to fail in doing well enough for what they should be doing. So far I have been able to get those failures replaced and so I’m fine with that.

When they work they are one of the greatest things out there. You just wave your reader over the sensor 20 times a day if you want. But when they don’t it can be pretty bad. The ones I have had replaced have been just too big of a difference or an erratic difference. If it is always going to be say about 20 points lower I just always dose at the 20 points. But when it’s 20 and the next time it’s 60, forget it. Or even the ones that are 40 when you are low, then it’s just too far off to figure out what’s going on.

What I have done with the last 3 + is put the new one on about 18-24 hours before the old one runs out, and I think the 24 hour frame works better, you put the new one on before the old one runs out, with a second reader. Because the new ones for me are highly inaccurate the first at least 4 hours plus. So if I have a 12 hour window I can test both constantly without a lot of fingersticking to get an accurate idea of how the new one is reading.

Warning, I’m sure it will happen at some point, but I have not mixed up the readers yet for each sensor. Hopefully when I do it, it won’t change anything if I don’t give it a ok to change.

This has allowed me to go a week plus with no fingersticking with no worries. And I have to tell you I am already so spoiled about not wanting to do fingersticking unless I have to!!! And if you haven’t had a CGM before it makes a world of difference to know what your BG is doing every hour of the day!

So I have to say I love the sensors as long as they work right. And as long as they keep replacing the ones that don’t work properly. That is really the key, as long as they keep replacing them. Lol, as of right now I’m happy with them, I can’t say that won’t change, but I have also found it seems to make a difference who you talk to at Libre. It just has made it so easy to check my BG as often as I want to and a plus, it’s small and easy to wear.


#120

Good to know they will replace. I’m only on sensor two, and I dont even like the roche meter I got from the My Sugr people, but it has been within maybe five points. I check extreme highs or lows anyway, so no big deal to me. Certainly better than my old days with no trending info!