FDA: Glucose meter malfunction could be fatal
The Food and Drug Administration (FDA) classifies LifeScan's recall of its SureStep home blood glucose meters as Class I, indicating that there is a reasonable probability that the product will cause serious health complications or death. All SureStep home blood glucose meters manufactured prior to August 1997 have been recalled because the meters may give an error message, "Er 1," instead of a "HI" reading when a patient has very high blood sugar levels. LifeScan is a Milpitas, CA-based subsidiary of Johnson and Johnson.
At least two people who received an "Er 1" message on their SureStep meters have died, reports the FDA. The diabetics had very high blood glucose levels, but delayed seeking medical care. "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," according to a statement issued by the FDA. "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."
LifeScan is replacing, free of charge, all meters with serial numbers whose first five digits begin with L6000 through L7205 and meters with serial numbers L7206-GA-00001 through L7206-GA-01128. In the interim, the company is issuing warning stickers for its customers to place on the glucose meters to remind them that "Er 1" can mean "HI." More information is available from the company's 24-hour customer service line at (800) 951-7226.
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