Health

FDA Issues Diabetes Warning

July 28, 1998 / 9:43 PM EDT / AP

The government has urged diabetics to check immediately to see whether they're using a defective blood glucose monitor, saying the manufacturer may have misled patients into thinking the recall was less serious than it is.

The Food and Drug Administration's unusual warning came a month after LifeScan Inc. recalled certain SureStep glucose meters that sometimes flash an error message when diabetics actually have dangerously high blood sugar.

The malfunction - which is only in meters made before August 1997 - earned FDA's most serious recall classification, and there are two possibly related deaths. But the FDA is concerned that LifeScan is downplaying the danger.

"LifeScan has characterized this as a product replacement program" instead of a Class 1 recall, the FDA said in a statement Tuesday. "FDA is concerned that some diabetics, wholesalers and distributors who purchased these meters may be misled."

"We don't believe we have" misled customers, responded Jeffrey Leebaw of Johnson & Johnson, LifeScan's parent company. "People are working very hard and diligently on this."

Blood glucose meters commonly flash error messages if patients didn't test enough blood or had some other minor problem.

But the recalled SureStep meters sometimes flash an "Er 1" error message when patients really have very high blood sugar.

Don't stop using the meters without a replacement, the FDA stressed. Instead, diabetics who get an "Er 1" message should see if the blue dot on their test strip is as dark or darker than the darkest blue oval on the color chart that comes with their test strip bottle. If so, they likely have very high blood sugar and should call a doctor immediately.

California-based LifeScan needs several months to manufacture enough new monitors to replace, for free, the estimated 290,000 sold. Meanwhile, LifeScan is supposed to mail customers warning stickers reminding monitor users how to interpret an "Er 1" message. A warning sticker might have helped in one death, where a caretaker didn't know what the error message meant, the FDA said.

The serial numbers of recall meters begin "L6000" through "L7205," and also include "L7206-GA-00001" through "L7206-GA-01128." Anyone with those monitors should call 1-800-951-7226 for a replacement.