FDA Warns Maker of Blood-Sugar Monitors

WASHINGTON - The FDA has warned a California company over problems with its blood-sugar monitors, used by million of diabetics around the world.

The Food and Drug Administration said LifeScan Inc., a Johnson & Johnson subsidiary, did not meet agency manufacturing standards and failed to properly investigate reports of serious health problems associated with its OneTouch Ultra and UltraSmart blood-glucose monitors.

The letter, dated Dec. 7 but posted to the FDA Web site on Tuesday, stemmed from an inspection of the Milpitas, Calif. company that began April 6.

Six days after the inspection began, LifeScan warned that users of the glucose monitors could unwittingly change the unit of measure on the devices and misinterpret their results. Two days after that, the company said it had received 40 reports of problems from the misreadings, including what it called "temporary periods" of high or low blood sugar in diabetic patients who required medical attention as a result.

http://news.yahoo.com/s/ap/20051221/ap_on_he_me/glucose_monitors

to us free, but we are using a different type because the pharmacist recommended it. Think we will stick with what we have.

for the past several months- while pregnant. The article doesn't explain exactly what the cause is, or how to avoid altering the unit of measurement. Would like to know more, guess I'll be calling them today.