Complaint resolution service publishes case studies, recall information and consumer news.

The U.S. Food and Drug Administration (FDA) is alerting the public to counterfeit blood glucose test strips being sold in the United States for use with various models of LifeScan, Inc., One Touch Brand Blood Glucose Monitors used by people with diabetes to measure their blood glucose.

The counterfeit test strips potentially could give incorrect blood glucose values–either too high or too low–which might result in a patient taking either too much or too little insulin and lead to serious injury or death. No injuries have been reported to FDA to date.

The counterfeit test strips are:

* One Touch Basic®/Profile® (lot #272894A, 2619932 or 2606340) test strips; and,
* One Touch Ultra® (lot #2691191) test strips.

Consumers who have the counterfeit test strips should stop using them, replace them immediately and contact their physician. Consumers with questions may contact the company at 1-866-621-4855.

The counterfeit test strips were distributed to pharmacies and stores nationwide–but primarily in Ohio, New York, Florida, Maryland and Missouri–by Medical Plastic Devices, Inc., Quebec, Canada and Champion Sales, Inc., Brooklyn, N.Y.

The counterfeit test strips can be identified by the following characteristics:

Counterfeit One Touch Basic/Profile Test Strips

* Lot Numbers 272894A, 2619932 or 2606340
* Multiple Languages- English, Greek and Portuguese text on the outer carton
* Limited to 50-Count One Touch (Basic/Profile) Test Strip packages

Counterfeit One Touch Ultra Test Strips

* Lot Number 2691191
* Multiple Languages- English and French text on the outer carton
* Limited to 50-Count One Touch Ultra Test Strip packages

LifeScan alerted FDA of the counterfeit test strips. The agency is investigating the matter.

LifeScan is alerting the public via a press release and is notifying pharmacists, distributors, and wholesalers through a letter. In its letter, the company is advising customers to contact their original source of supply for restitution. For more information, visit: www.GenuineOneTouch.com.

FDA is alerting its Counterfeit Alert Network partners, a coalition of healthcare professional, consumer and trade associations, who have agreed to further disseminate this important information in a timely and effective manner.

Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD, 20852-9787, or through the MedWatch Web site at www.fda.gov/medwatch.

Posted under Customer Service, Products

A letter from Barbara J. Cassens, a District Director with the US Food and Drug Administration, has warned LifeScan, Inc., of deficiencies within its OneTouch Ultra and OneTouch UItraSmart Blood Glucose Meters manufacture and distribution.

Citing five different complaints that did not receive a response or complete investigation, Cassens’ December 7 letter to LifeScan’s Chairman Eric P. Milledge said that “…our investigators determined that you are manufacturing the OneTouch Ultra and the OneTouch UltraSmart Blood Glucose Meters in violation of the Federal Food, Drug, and Cosmetic Act (the Act).” Cassens’ letter also gave the company 15 “working” days to respond to the allegations. It was unclear how the Christmas holiday would impact that date, if at all. Regardless, the deadline for any such response is imminent if not already passed.

Neither the FDA nor (shockingly) LifeScan has any information following-up this issue on their web sites.

This is not the first time that LifeScan has run afoul of the FDA. According to a March 2001 issue of IVD Technology, the company was “ordered to pay a criminal fine of $29.4 million and an additional $30.6 million in civil penalties, damages, attorneys’ fees, and restitution to the U.S. government.” LifeScan was also reportedly placed on probation for three years.

MedicineNet.com says that LifeScan estimates that 4.7 milion diabetics use the company’s devices to monitor their blood sugar — the key measurement that almost every medical person agrees is critical to reducing long-term health risks and complications associated with diabetes.

Posted under Health