J&J Recalls All OneTouch Verio IQ Glucose Meters Worldwide

Disclosures

March 25, 2013

The LifeScan unit of Johnson & Johnson is voluntarily recalling almost 2 million of its OneTouch Verio blood glucose meters because they malfunction at extremely high blood glucose levels, LifeScan announced today.

The recall includes 1.2 million meters sold worldwide under the brand name OneTouch Verio IQ, LifeScan spokesperson David Detmers told Medscape Medical News. Of those, 90,000 are in the United States. Also recalled are 670,000 OneTouch Verio Pro meters in Europe, and 4,900 OneTouch Verio Pro + meters used in hospitals and clinics in various markets outside the United States.

Each of the 3 One Touch Verio models malfunctions a bit differently at blood glucose levels of 1024 mg/dL and higher.

  • The OneTouch Verio IQ fails to displays the standard warning message "Extreme high glucose above 600 mg/dL" and instead shuts off.

  • The OneTouch Verio Pro displays and stores an incorrect reading, which is the actual blood glucose level minus 1024 mg/dL.

  • The OneTouch Verio Pro + correctly displays the warning message but stores an incorrect reading — again, the actual blood glucose level minus 1024 mg/dL.

LifeScan is advising US patients using the OneTouch Verio IQ meter to call 1-800-717-0276 to receive a free replacement. They can continue using their current meter in the meantime as long as they understand the defect, according to LifeScan. However, an unexpected shutoff during testing could indicate extreme hyperglycemia, which warrants contacting a healthcare professional.

The likelihood of anyone experiencing a blood glucose level of 1024 mg/dL is remote, but possible, LifeScan stated in a press release. "Because [the OneTouch Verio IQ meters] do not provide an appropriate warning...diagnosis and treatment of extreme hyperglycemia may be delayed or incorrect treatment may be given resulting in potentially serious health risk or fatality."

US clinicians are instructed to stop distributing OneTouch Verio IQ meters to patients and call 1-877-644-0004 to arrange a pickup of samples.

In contrast, patients in Europe with OneTouch Verio Pro meters should stop using them immediately because of their false readings at 1024 mg/dL and above. Clinicians can continue to use the OneTouch Verio Pro + while they wait for a replacement as long as they do not rely on readings stored in the device, according to LifeScan's David Detmers.

So far, LifeScan has not received reports of any adverse events related to malfunctions of the OneTouch Verio IQ and Pro + models at extremely high blood glucose levels. The company has learned of 1 adverse event linked to the OneTouch Verio Pro meter, but has not determined whether there is a causal relationship.

More information about the recall is available on the Johnson & Johnson Web site.

To report problems with OneTouch Verio IQ blood glucose meters, contact MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available at http://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.

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