Class 1 Recall: Animas Corporation, Battery Caps Used with the OneTouch Ping System, Animas 2020 Insulin Pump, Animas IR1200 Insulin Pump, and Animas IR1250 Insulin Pump
Date Recall
Initiated: August 4, 2008
Product: Battery caps used with the OneTouch Ping System, Animas 2020 Insulin Pump, Animas IR1200 Insulin Pump, and Animas IR1250 Insulin Pump
The battery caps used with the above infusion pumps were manufactured from June 1, 2008 through July 31, 2008, and were distributed from June 16, 2008 through August 1, 2008.
Use: An insulin pump helps administer insulin to maintain proper levels of blood glucose.
Recalling Firm: Animas Corporation
200 Lawrence Dr
West Chester, Pennsylvania 19380
Reason for Recall: There may be an intermittent loss of contact between the battery cap and the battery compartment in the pump which may result in the device resetting. This can cause the device to stop administering insulin, which could result in an excess level of glucose in the blood (hyperglycemia). Additionally, this failure may lead to user confusion in the amount of insulin administered, contributing to errors in future doses, which may result in lower than normal level of glucose in the blood (hypoglycemia).
Public Contact: The company may be contacted Monday through Friday at 1-866-423-4087 from 8:00 a.m. until 7:00 pm Eastern Standard Time.
FDA District: Philadelphia
FDA Comment: Between August 18, 2008 and September 1, 2008, the company sent letters to the patients by certified mail to inform them that the defective battery cap may not maintain contact with the pump’s battery compartment. As a result, the affected pump may inadvertently shut down. The company included replacement battery caps with the letter.
The company advised their patients to immediately replace the battery cap on their insulin pump with a battery cap enclosed with the letter. Patients were directed to follow the instructions in the User Guide for changing the battery cap. Patients were also instructed to discard the defective battery caps and discontinue any further use of them.
The company also sent letters to their distributors alerting them to the battery cap failure on the insulin pumps and provided instructions for retrieval, replacement, and disposal of the defective battery caps.
The company is continuing their efforts to contact all patients who have not acknowledged receipt of the letter.
For more information about this recall, please see the company’s recall announcement at: http://www.animascorp.com/ViewAnnouncements.aspx?ID=88
Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.
Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of these products to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.
For additional information, see FDA’s Press Release at http://www.fda.gov/bbs/topics/NEWS/2008/NEW01911.html
Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.
Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of these products to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.
Online:www.fda.gov/MedWatch/report.htm
Regular Mail: use postage-paid FDA form 3500 available at: MedWatch: The FDA Safety Information and Adverse Event Reporting Program | FDA
Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
FAX: 1-800-FDA-0178