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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
July 28, 1998

LIFESCAN SURESTEP BLOOD GLUCOSE METERS RECALLED

In early June, LifeScan Inc., a subsidiary of Johnson & Johnson, announced it was replacing some of its SureStep blood glucose meters used by diabetics to test their blood sugar level because some of the meters were giving confusing error readings. LifeScan has characterized this as a product replacement program. However, FDA is concerned that some diabetics, wholesalers and distributors who purchased these meters may not realize this product replacement is for a potentially serious malfunction.

Because a confusing error message can put diabetics at serious risk, FDA is providing the following information: LifeScan is recalling and replacing its SureStep home blood glucose meters manufactured before August 1997 because the meters may give an error message ("Er-1") instead of "HI" (high) when a person's blood sugar is very high--500 mg/dL or greater. Such a level is very dangerous
if not recognized and treated and could result in hospitalization or death.

FDA has received reports of two deaths in people whose glucose was very high but who repeatedly got error message readings from the SureStep blood glucose meters and who delayed seeking medical care.

FDA has classified LifeScan's recall as a Class I recall, that is, a situation in which there is a reasonable probability that the use of the product will cause serious adverse health consequences or death.

People using the affected SureStep meters need to know that an "Er 1" message may actually mean a very high level of blood sugar instead of an error. If users get an "Er 1" message, they need to use the visual color change indicator to see if their blood sugar is too high. They must
compare the blue color dot on the test strip to the color chart on the test strip bottle. If the dot on the strip is as dark or darker than the color chart, it indicates very high blood sugar, and they should contact a health professional immediately.

Diabetics who use these SureStep brand glucose meters should not stop testing their blood sugar levels. They can continue to test with these meters as long as they know that an "Er l" message can actually mean a very high level of blood sugar. It is far more dangerous not to check blood sugar levels than to use a blood glucose meter that may give an unclear error message at high glucose levels.

LifeScan is replacing all affected meters free of charge. Meanwhile, the company, located in Milpitas, Calif., is sending its customers warning stickers to put on the machines as reminders that the "Er l" message could actually mean very high blood sugar.

All meters with serial numbers whose first five digits begin with L6000 through L7205, and meters with serial numbers L7206-GA-0000l through L7206-GA-01128 are affected and should be replaced. The serial number can be found on the back of the meter. People with these machines should call LifeScan's 24-hour customer service line at 1-800-951-7226 to arrange for replacement or to get further information. Other types of blood glucose meters made by LifeScan are not affected.

 

The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.