Abbott sends notification of possible blood glucose meter error
If dropped, screen may not properly show test results
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On August 31, 2007, Abbott issued a worldwide medical device correction for consumers using its Precision Xtra™, Optium™, ReliOn® Ultima, Rite Aid® and Kroger® blood glucose meters manufactured after January 31, 2007. The company said the meter, if dropped on a hard surface, may not display test results properly, which could cause a risk of undetected hypoglycemia or hyperglycemia.
Abbott Diabetes Care noticed the error through testing recently produced meters that were dropped onto a hard surface. Part of the display can be disconnected or jarred, making it difficult to read the information, or the unit may not display the information at all.
Glucose meters should be kept in the wallet provided with the meter to offer additional protection, the company said. If a patient does drop a meter on a hard surface, a meter display check should immediately be performed. Instructions on how to do this are in the users guide.
Patients whose meters’ display screen is not working should immediately stop using their meters and call Abbott Diabetes Care for assistance at 1-877-844-4404. The Abbott Diabetes Care center can also help patients determine if their meter was manufactured after January 31, 2007.
For more information, patients may visit the company’s website. Source: “Urgent: Abbott Notifies Users of Precision Xtra™, Optium™, ReliOn® Ultima, Rite Aid® and Kroger® Blood Glucose Meters to Check Display Screens,” US Food and Drug Administration Press Release, August 31, 2007.

