Class 1 Recall: Bayer Ascensia® Contour® Blood Glucose Monitoring System

Bayer Ascensia® Contour® Blood Glucose Monitoring System, Product 7152A. The system consists of a meter, test strips contained in a dry (desiccated) bottle, a bottle of test solution, a lancing device and lancets, and instructions for use.

Serial numbers include: 1475139, 1688643, 1841620, 1852071,2064303, 2064306, 2064329, 2064601, 2086449, 2203283, 2221308, 2263059, 2263260, 2280056, 2317037, and 2319010

These meters were distributed from March 23, 2007 through May 31, 2007.

Diabetes patients use blood glucose meters to measure the amount of glucose in their blood, and as an aid in monitoring the effectiveness of diabetes management in the home and/or by healthcare professionals in healthcare facilities.

The meters reported the wrong units of measure for Canadian users. Instead of mmol/L, which is the appropriate measurement for Canadian users, the meters were reporting mg/dL. Contractors change the meters to the appropriate units of measure before they are packaged. The contractor shipped 32 meters to Canada that were distributed with the wrong unit of measure (mg/dL - units used in the U.S.) instead of mmol/L. Consumers may misinterpret the blood glucose results displayed by the meter and adjust treatment according to the misinterpreted result. They may overestimate the glucose value by 18 times what they actually are and over treat themselves. Consumers may have a reaction of hypoglycemia but its symptoms may prevent them from self- treatment. Also, some consumers may lack the classic signs of hypoglycemia to receive proper treatment.

The firm began calling its Canadian customers on or about June 6, Comments: 2007 to inform them of the problem, to tell them that a meter with the correct measurement units will be sent to them, and to request that they return the meter currently in their possession. Canadian health officials were notified via email on June 12, 2007 and reportedly informed Bayer that a press release was not necessary due to the limited number of units involved.

Bayer determined that only 16 of the meters had been further distributed beyond the distribution facility in Canada, although 32 correct meters had been shipped to Canada.

As of June 11, 2007, the 16 distributed were accounted for as follows: 2 were returned by customers, 7 were located in Canada at distributor or retailer warehouses, 2 were located with customers using the warranty database and the remaining 5 are presumed sold but have not been located.

On June 11, 2007, the contractor added a verification check to its software. Bayer is verifying that all stock on hand have been configured properly for units that were supposed to have been reconfigured before the controls went into affect.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.

Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of this product 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: www.fda.gov/MedWatch/getforms.htm
  Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
  
• FAX: 1-800-FDA-0178