Blood glucose meters

General information

There are various makes of meters used for measuring the blood glucose concentration. On occasion, some have been found to give false readings.

In early June 1998, the manufacturers of SureStep blood glucose meters (LifeScan) announced that they were going to replace some of the meters used by diabetics to test their blood sugar concentration because they were giving confusing error readings. SureStep home blood glucose meters manufactured before August 1997 may have been giving an error message (“Er-1”) instead of “HI” (high) when a blood sugar concentration was very high—500 mg/dl (28 mmol/l) or greater. Such a concentration is potentially dangerous if not recognized and treated, and could result in hospitalization or death. The FDA had 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 was concerned that some diabetics, wholesalers, and distributors who purchase these meters might not realize that this product replacement procedure concerns a potentially serious malfunction [ ]. The FDA 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 needed to know that an “Er-1” message might actually mean a very high concentration of blood glucose instead of an error. If users got an “Er-1” message, they needed to use the visual color change indicator to see if their blood glucose was too high. They had to compare the blue dot on the test strip to the color chart on the test strip bottle. If the dot on the strip was as dark as or darker than the color chart, it indicated a very high blood glucose, and they were advised to contact a health professional immediately.

People with diabetes who use the SureStep brand glucose meters were advised not to stop testing their blood glucose concentrations. They could continue to test with these meters as long as they knew that an “Er-1” message could actually mean a very high concentration. It was considered far more dangerous not to check blood glucose than to use a blood glucose meter that might give an unclear error message at high glucose concentrations.