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[IP] Re: LifeScan Monitor

Tuesday July 28 7:36 PM EDT 

FDA recalls blood sugar monitors

NEW YORK, Jul 28 (Reuters) -- All SureStep home blood glucose meters 
manufactured prior to August 1997 have been recalled by the manufacturer, the US
Food and Drug Administration (FDA)
announced on Tuesday. 

These SureStep blood glucose meters, manufactured by LifeScan Inc., may give an 
error message, "Er 1," instead of a "HI" reading when a person has very high 
blood sugar levels. The faulty reading was
classified by the FDA as a "situation in which there is a reasonable probability
that the use of the product will cause serious adverse health consequences or 

At least two people who received an "Er 1" message on their SureStep meters have
died, reports the FDA. In both of these cases, 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

In early June, LifeScan Inc, the Milpitas, California-based subsidiary of 
Johnson and Johnson, announced a plan to replace SureStep home glucose meters 
because of the faulty readings. But according to a
statement issued Tuesday, the FDA "is concerned that some diabetics, 
wholesalers, and distributors who purchased these meters may... not realize this
product replacement is for a potentially serious

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 1-800-951-7226. 

Other types of blood glucose meters made by LifeScan are not affected, according
to the FDA statement. 

Insulin-Pumpers website http://www.bizsystems.com/Diabetes/