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FDA Warns Maker of Blood-Sugar Monitors

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


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.

The FDA letter cited five such incidents where patients had to be hospitalized. LifeScan failed to properly investigate the incidents, the FDA said.

The company stopped shipping the monitors this spring and has since redesigned them.

"LifeScan has implemented a number of corrective actions," the company said in a statement. "The recent warning letter acknowledged that many of the new procedures are adequate. However the agency has requested additional information to better understand the further improvements we plan to make."

The company estimates 4.7 million people worldwide use its blood-glucose monitors.

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