STATSTRIP GLUCOSE HOSPITAL METER

Additional Manufacturer Narrative

THERE WAS NO REPORT OF PATIENT HARM OR ANY INTERVENTION REQUIRED. THERE CURRENTLY IS A PENDING INVESTIGATION. NOVA IS REQUESTING ADDITIONAL INFORMATION, AND FURTHER DETAILS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem

THE CUSTOMER INDICATED THAT THEIR STATSTRIP WIRELESS METER, SERIAL NUMBER: (B)(4). GLUCOSE RESULT THAT WAS HIGH COMPARED TO THE READINGS REPORTED FROM ANOTHER METER.

Additional Manufacturer Narrative

UDI: (B)(4). THE CUSTOMER INDICATED THAT THEIR STATSTRIP WIRELESS METER REPORTED GLUCOSE RESULT THAT WAS HIGH COMPARED TO THE READINGS REPORTED FROM ANOTHER METER. DHR REVIEWS FOR THE STATSTRIP GLUCOSE METER, SN (B)(6), AND STATSTRIP GLUCOSE TEST STRIPS, LOT 0321243249, WERE PERFORMED BY THE SR. QUALITY CONTROL MANAGER. THE REVIEWS INCLUDED AN ASSESSMENT OF THE PRODUCTION, TESTING, AND RELEASE OF THE METERS AND TEST STRIP BATCH. NO ABNORMALITIES OR CONCERNS WERE OBSERVED; THE DHRS INDICATED THAT THE RELEASED PRODUCT MET ALL SPECIFICATIONS. THE NOVA CLINICAL APPLICATIONS DEPARTMENT PERFORMED A MINI CORRELATION STUDY WHICH CONCLUDED THAT THE STATSTRIP GLUCOSE METER, SN (B)(6), HAS A GOOD CORRELATION TO THE LABORATORY REFERENCE METHOD. THE METER MEETS THE RECOMMENDED POCT12-A3 CLINICAL ACCURACY STANDARD. RETAIN STATSTRIP GLUCOSE TEST STRIPS, LOT 0321243249, MET THE PERFORMANCE ACCEPTANCE CRITERIA FOR LINEARITY AND WHOLE BLOOD SPECIMENS. ALL LINEARITY RESULTS WERE WITHIN RANGE AND NO DISCREPANT RESULTS WERE OBSERVED FOR WHOLE BLOOD SAMPLES. NO FURTHER ACTION IS REQUIRED AT THIS TIME, NOVA WILL CONTINUE TO MONITOR FOR RECURRENCE.