FDA Warns J&J Unit on Blood-Glucose Test Problems

By DOW JONES/The Associated Press

WASHINGTON – The Food and Drug Administration warned a unit of New Brunswick-based Johnson & Johnson for failing to properly investigate and report problems with blood-glucose tests used by people with diabetes.

The warning letter, sent to Milpitas, Calif.-based LifeScan Inc., was posted Tuesday on the FDA’s Web site.

In April, the company said consumers could accidentally change the unit of measure and misinterpret their blood-glucose results when using the blood-glucose tests.

The company notified users of the problem and how to fix it.

The company also redesigned the meters, which are sold in the United States as OneTouch Ultra and OneTouch UltraSmart blood- glucose meters.

The FDA letter, dated Dec. 7, stemmed from an inspection conducted from April 6 to June 30 at the firm’s California manufacturing facility.

The agency said LifeScan is not in compliance with the FDA’s manufacturing regulations and that it failed to properly investigate and report complaints involving the blood-glucose devices.

The FDA cited at least five instances where consumers reported problems with the blood-glucose meters, including complaints that the OneTouch Ultra was set to the wrong unit of measurement that the company did not investigate.

In April, LifeScan said it received 40 reports worldwide of adverse events associated with the meters being set to the incorrect unit of measure. The events have generally consisted of temporary periods of high or low blood sugar, some of which required medical attention.

A LifeScan spokesman was not available to comment.J&J shares fell 41 cents to close at $60.78 on Tuesday on the New York Stock Exchange.