United States of America. In early June 1998, the manufacturer of SureStep blood glucose meters (LifeScan), announced that it was replacing some of the meters used by diabetics to test their blood sugar level because they were giving confusing error readings. The FDA is concerned that some diabetics, wholesalers and distributors who purchased these meters may not realize that this product replacement procedure concerns a potentially serious malfunction.

Therefore, the 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.

The 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 delayed seeking medical care.

The 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 colour change indicator to see if their blood sugar is too high. They must compare the blue colour dot on the test strip to the colour chart on the test strip bottle. If the dot on the strip is as dark or darker than the colour 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-1” 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 and meanwhile is sending customers warning stickers to put on the machines.

Reference: HHS News P98-20 dated 28 July 1998.