• E-mail
• Print
• Comment
• Font Size
• Digg
• del.icio.us
• Discuss article

FDA Warns J&J Unit on Blood-Glucose Tests

Posted on: Tuesday, 20 December 2005, 18:00 CST

WASHINGTON - The Food and Drug Administration warned a unit of 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 to 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, 2005, 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.

The FDA said that 97 percent of complaints logged from July 2002 to July 2004 were listed as "user error," according to an FDA review of complaints about the glucose tests. The company then began an investigation into the complaints and the devices.

The FDA said LifeScan also failed to report problems with the devices to the agency within 30 days.

FDA rules require companies to report problems with devices that may have caused or contributed to a death or serious injury or in instances where a device failure could contribute to a death or serious injury if the malfunction were to recur.

In April, LifeScan said it received 40 reports worldwide of adverse events associated with the meters being set to the incorrect unit of measure, which in some cases happened when consumers were setting the meter's date and time. The events have generally consisted of temporary periods of high or low blood sugar, some of which required medical attention.

An accidental change in the meter's unit of measure can contribute to people with diabetes misunderstanding their test results and managing their diet or medication in a way that can result in temporary periods of high or low blood sugar.

A LifeScan spokesman was not immediately available to comment on the FDA's letter or provide updated figures on the number of adverse events related to the blood-glucose tests.

In its letter, the FDA said LifeScan has attempted to address the problems raised by the FDA in the April-June inspection, and said the steps the company is putting into place to address the concerns "appear to be adequate." But the FDA said "various corrective actions have not been completed."

The FDA said it is still awaiting results of testing LifeScan has done on returned glucose meters, as well as a report on the investigation of the top 10 complaints of all OneTouch Ultra complaints, among other things.

J&J shares fell 41 cents to close at $60.78 Tuesday on the New York Stock Exchange.

Source: Associated Press/AP Online

More News in this Category