NOVA STATSENSOR CREATININE HOSPITAL METER

Additional Manufacturer Narrative

ACCORDING TO THE RADIOLOGY MANAGER AND LAB DIRECTOR IN A FOLLOW UP CALL WITH (B)(6) MEDICAL CENTER; IT IS STILL UNKNOWN IF THERE WAS AN ADVERSE EFFECT FROM THE CONTRAST BEING ADMINISTERED. ACCORDING TO THEM,"... THERE WAS NOTHING REMARKABLE ABOUT THE PATIENT OR THE TEST; THE PATIENT BLED WELL AND THERE WEREN'T ANY ERRORS GENERATED..." THEY ARE GOING TO CONTINUE TO MONITOR PATIENT RESULTS AND MAKE SURE THEY ARE CORRELATING WITH THE LAB.

Description of Event or Problem

THE STATSENSOR METER REPORTED A RESULT OF 1.97MG/DL (EGFR 37) AND THE LAB REPORTED A RESULT OF 3.60MG/DL (EGFR 17). THE HOSPITAL'S POLICY SAYS TO GIVE CONTRAST DYE WHEN THE EGFR IS GREATER THAN 30, SO THEY DID. THEY ONLY LATER FOUND OUT THAT THE EGFR WAS 17 AND REALIZED THEY SHOULDN'T HAVE ADMINISTERED CONTRAST DYE. IT IS UNKNOWN IF THE PATIENT WAS ADVERSELY AFFECTED BY THIS.

Additional Manufacturer Narrative

SECTION WAS UPDATED TO REFLECT THE CORRECT PRODUCT IDENTIFICATION. COMPLAINT WAS NOT CONFIRMED. METER AND TEST STRIPS WERE NOT RETURNED. DHR REVIEWS WERE CONDUCTED ON BOTH THE METER AND STRIPS. THE DHR WAS COMPLETE AND CONTAINED ALL RELEVANT DATA INDICATING THE RELEASED PRODUCT MET ALL SPECIFICATIONS. RETAINED TESTING OF THE LOT REVEALED NO PERFORMANCE ANOMALIES. THE PERFORMANCE OF NOVA STATSENSOR CREATININE TEST STRIP LOT# 4916348129 PASSES ALL ACCEPTANCE CRITERIA FOR LINEARITY SOLUTIONS AND BLOOD SAMPLES. RESULTS FOR LINEARITY SOLUTIONS ARE WITHIN THE LINEARITY SOLUTION RANGES. NO DISCREPANCIES WERE OBSERVED BETWEEN THE BLOOD RESULTS OBTAINED BY RETAINED NOVA STAT SENSOR CREATININE TEST STRIPS.