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From:
Fran Gillespie <[log in to unmask]>
Date:
Fri, 5 Jun 1998 23:30:36 -0700
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<<Disclaimer: Verify this information before applying it to your situation.>>

Lifescan Inc.  is recalling its SureStep consumer blood glucose meters made
before August 1997 because they may give certain diabetics an ``error''
message instead of saying their blood sugar is too high.

The Food and Drug Administration stressed Thursday that diabetics should not
stop using the glucose meters -- patients who get this confusing message can
take other steps to double-check their blood sugar while they await a
replacement machine.

``The issue is to alert patients so they don't get into trouble by
misunderstanding their 'Error-one' message,'' said FDA's Dr.  Susan Alpert.

Blood glucose meters commonly flash error messages that signal patients to
test their blood again because they didn't use enough blood or had some other
problem.

But SureStep meters made before August 1997 sometimes flash an ``Er 1'' error
message when patients really have very high blood sugar, LifeScan said.

Patients who get that message should compare the blue dot on their test strip
with the color chart that comes with their test strip bottle.  If the dot is
as dark or darker than the chart's darkest blue oval, they likely have very
high blood sugar and should call a doctor immediately, LifeScan said.

The FDA has reports of four hospitalizations and two deaths possibly related
to the problem, but cautions that there's no proof of a link.

California-based LifeScan already had tracked down 180,000 customers to
explain the color chart system.  But the company had sold 290,000 meters.  So
Thursday, LifeScan publicized the precautions, and set up a toll-free phone
line for customers to get in line for a free replacement meter.

Replacements will take several months, LifeScan said, emphasizing the
importance of continuing to use the meter and just double-check error
messages.

SureStep meters manufactured before August 1997 have serial numbers that
begin with ``L6000'' and continue through ``L7205.'' Serial numbers beginning
with ``L7206'' were made after August, when LifeScan says it corrected the
software problem.

          ------

For questions or for a free replacement meter, call 1-800-951-7226.

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