Lifescan glucose meter error could be fatal
The Food and Drug Administration (FDA) has classified LifeScan's recall of its SureStep home blood glucose meters as a Class I recall, indicating that there is reasonable probability that the product will cause serious adverse health consequences or death.
In early June, LifeScan Inc., a subsidiary of Johnson & Johnson, announced it was replacing certain blood glucose meters because they were giving faulty readings. LifeScan described the decision as a product replacement program. But the FDA is concerned that some diabetics, wholesalers and distributors who purchased these meters may be misled and not realize this product replacement is for a potentially serious malfunction.
The FDA says SureStep home blood glucose meters manufactured before August 1997 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.
The FDA has received reports of two deaths in people whose blood glucose levels were very high but who repeatedly got error message readings from the SureStep meters and delayed seeking medical care.
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.
The FDA urges diabetics who are using these SureStep blood glucose meters to continue testing their blood. They can use the meters as long as they verify "Er 1" messages with the visual color change indicator. The company is replacing all the affected meters free of charge, and is sending out warning stickers to all customers to remind them that an "Er 1" 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 L72006-GA-00001 through L7206-GA-01128 are affected and should be replaced.
For more information on the recall, or to arrange replacement of an affected meter, call LifeScan's 24-hour customer service line at (800) 951-7226.
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