Spot Recall of Freestyle / Omnipod Test Strips by Abbott

Diabetes Technology Insulin Pumps
1

Notice of test strips that read low for Freestyle meters and Omnipod. I think it's interesting that they included some Freestyle Lite test strips on this list but only if used in Freestyle meters. If you use a Freestyle Lite meter you are not affected.

I did not have any of these lot numbers. I get my strips from Express Scripts. I feel like I won the reverse lottery.

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https://www.abbottdiabetescare.com/press-room/2013/2013-g.html

Important Urgent Product Recall FreeStyle® and FreeStyle Lite® Test Strips

November 20, 2013

Dear Valued Customer,

Recently, it has come to our attention that certain lots of FreeStyle® and FreeStyle Lite® Blood Glucose Test Strips produce erroneously low blood glucose results when using FreeStyle® Blood Glucose Meters, FreeStyle Flash® Blood Glucose Meters and the FreeStyle® blood glucose meter built into the OmniPod® system. Erroneously low results that are not recognized may pose significant risks to your health.

If you do not use the meters in the photographs below, your blood glucose test results are not affected and you do not need to read any further.

FreeStyle Flash® Blood Glucose Meter
FreeStyle® Blood Glucose Meter
OmniPod®

The FreeStyle® and FreeStyle Lite® Blood Glucose Test Strips lots listed below may give out of range control solution results and produce erroneously low blood glucose results when using the Blood Glucose Meters illustrated in the photographs above.

The affected FreeStyle® and FreeStyle Lite® Blood Glucose Test Strips lots are found in the table below:
Lot Numbers
1281732 1283345 1283603 1285007 1350414 1363015 1363109
1363321 1365056 1365920 1365921 1365934 1366006 1366111
1366337 1366347 1366515 1367917 1373262 1374907

A test strip insert is included with every carton of test strips, and provides very important product information. Please read your test strip insert carefully to ensure that you are using the correct Blood Glucose Meter for your test strip type.

If you have affected product, we recommend you take the following steps:

Call Abbott Diabetes Care Customer Service immediately at 1-888-736-9869 for replacement of the affected test strips. When you call, Abbott will send you unaffected FreeStyle® and FreeStyle Lite® Blood Glucose Test Strips at no charge.
While waiting for your replacement strips to arrive, either use an alternate method to measure your blood glucose (such as test strips from an unaffected lot number or a different blood glucose monitoring system). This issue only affects the lot numbers which are detailed in the table above when using FreeStyle® Blood Glucose Meters, FreeStyle Flash® Blood Glucose Meters.

If the only test strips available to you are from affected lots, do not stop testing your blood glucose. Control solution should be used to check the performance of your test strips and meter until you receive your replacement test strips. However, if any reading from a strip appears lower than you would expect or does not seem to match the way you are feeling, you should contact your health care provider. Pay special attention to signs and symptoms of high blood sugar (hyperglycemia).

Symptoms of high blood sugar may include: Excessive thirst, excessive urination, blurred vision, weakness, nausea, vomiting, and abdominal pain. If you are experiencing any of these symptoms or are not feeling well, contact your health care professional immediately.
Please dispose of the test strips in accordance with your local and state disposal regulations.

If the lot number of the test strips you are using is NOT in the table on this letter, you may continue to test your blood glucose as directed by your health care provider with your FreeStyle® Blood Glucose Test Strips.

There are no other Abbott Diabetes Care products impacted by this issue.

We recognize the importance of blood glucose testing and are committed to responding quickly to customers' requests for replacement test strips.

We want to assure you that our first priority is you, our customer. We sincerely regret any inconvenience this situation may cause. We thank you for your continued support of the FreeStyle Blood Glucose Monitoring System and Abbott Diabetes Care. If you have any further questions, please call Abbott Diabetes Care Customer Service at 1-888-736-9869.

2

Thanks very much for posting this.

3

Thanks for the heads up! Fortunately, I do not have any of the affected Lot numbers.... But at least I am aware of the problem and can be on the lookout for them when I get my next order of supplies... Thanks again!

4

Thanks for posting this. I did have an affected lot but didn’t find out until I was in the hospital giving birth to my son. My numbers were all over the place and we couldn’t figure what was wrong. Stupidly we trusted my meter over the hospital’s. We didn’t figure out the issue until two weeks post partum. I hate to think of all the lows I ate extra for and all the highs that were actually higher. Very scary!

Unfortunately Abbott was a huge pain about replacing my strips but they did.

5

Thanks for posting this.

I was having a problem for the past month and thought it was my G4, it wouldn't calibrate. I called Dexcom and they replaced my transmitter, yet with the new transmitter the problem continued. I finally checked my blood sugar with another meter and found the Omnipod reading 48 using the Freestyle Lite (the pharmacy sent me Lites a couple shipments ago and I used them, I know they're not approved but they seemed to have been ok until now) and the reading w/ a One Touch meter read 129. I called Insulet and they said the problem was using the Freestyle Lite test strips, even though I didn't have a problem until this past month. I called the pharmacy and they sent me a shipment of the regular Freestyle Strips and admitted it was their error when I was sent the Lite test strips.

I checked the Freestyle Lite strips I have left and they were not one of the 'affected' lot numbers... seems like they may have a few more bad lots out here.

6

I fully expect the recall to be expanded. These are probably just the ones they know about. I think your experience proves that. I am keeping an extra eye right now and double checking everything.

7

my lot was not included but I had two vials of test strips that were deemed defective. After the recall I put up a stink and all were replaced even though they weren't on the affected lots list

8

My PDM is acting up. It doesn't recognize that a test strip is in the machine - or it goes back to the home screen and starts the process over before I can use the test strip to test. I called Insulet. First she wanted to blame me - she implied that I didn't know to confirm my identity with the PDM before continuing. I have had this PDM for approximately 1 year. Then she wanted to know the source of my test strips. If I had received the strips directly from Abbott, she would know that it wasn't the strips or the supplier. The strips have an 8/2015 expiration. I received them from a pharmacy. Has anyone had a problem with Insulet 'not caring' about the PDM functioning, because the test strips used weren't supplied by Abbott directly? I finally gave up and will call during the week if the problem continues.

9

Update: I called Insulet again. They are overnighting me a new PDM.

10

Thank you for posting this