MEDLINE EVENCARE G3 GLUCOSE METER

Description of Event or Problem

PER CUSTOMER, "EVEN CARE G3 GLUCOSE METERS NOT READING IN RANGE WITH THE TEST STRIPS AND CONTROLS. I WAS TOLD IT MUST BE A METER ISSUE."

Additional Manufacturer Narrative

PER CUSTOMER, "EVEN CARE G3 GLUCOSE METERS NOT READING IN RANGE WITH THE TEST STRIPS AND CONTROLS. I WAS TOLD IT MUST BE A METER ISSUE. WE HAVE TO CHECK THE CONTROLS ON THE GLUCOSE METERS MULTIPLE TIMES BEFORE THE METERS WILL READ IN RANGE. SOMETIMES WE HAVE TO THROW OUT A NEW BOTTLE OF STRIP AND CONTROLS JUST TO GET THEM TO READ IN RANGE." THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, OR FOLLOW UP CARE. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.