STATSTRIP GLUCOSE HOSPITAL METER SYSTEM

Description of Event or Problem

THE COMPLAINANT REPORTED "CONFLICTING RESULTS BETWEEN 2 GLUCOMETERS AND PATIENT'S DEXCOM. NURSE ALSO SAID THE PATIENT'S DEXCOM WAS "OUT OF WACK" AS WHEN JUICE WAS GIVEN THE DEXCOM READING DID NOT CHANGE."

Additional Manufacturer Narrative

THE METER IN QUESTION WAS NOT RETURNED FOR ANALYSIS. THE METER WAS PASSING QC BEFORE AND AFTER THE SUSPECT RESULT. INCREASED FINGERSTICKS WERE DONE DUE TO POSSIBLE ERRONEOUS TEST RESULT. WITHOUT THE RETURNED PRODUCT A DETAILED INVESTIGATION ON THE FAILED PRODUCT COULD NOT BE PERFORMED, AND THE REPORTED CONDITION COULD NOT BE CONFIRMED. THIS COMPLAINT FILE SHALL BE CLOSED AS UNCONFIRMED AT THIS TIME. A DHR REVIEW WAS PERFORMED. NO ABNORMALITIES OR CONCERNS WERE OBSERVED. THE DHR INDICATED THE RELEASED PRODUCT MET ALL SPECIFICATIONS. A COMPARISON TO A REFERENCE ANALYZER WAS NOT PERFORMED. NO FURTHER ACTION IS RECOMMENDED AT THIS TIME. NOVA BIOMEDICAL WILL CONTINUE TO MONITOR FOR THIS OR SIMILAR EVENTS.