THE CUSTOMER OBSERVED LOWER THAN EXPECTED VITROS GENT RESULTS ON THREE DIFFERENT QUALITY CONTROL FLUIDS PROCESSED ON A VITROS 5,1FS CHEMISTRY SYSTEM USING VITROS GENT REAGENT, LOT 1512-09-3511.TDM LEV I VITROS GENT= 0.763 AND 0.739 VERSUS EXPECTED 2.73 UG/ML. BIORAD LEV 2 VITROS GENT= 3.4 VERSUS EXPECTED 5.3 UG/ML. BIORAD LEV 3 VITROS GENT = 5.0 VERSUS EXPECTED 7.9 UG/ML.BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. HOWEVER, NO VITROS GENT PATIENT SAMPLE RESULTS WERE QUESTIONED. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO OF THREE MDR?S FOR THIS EVENT. THREE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS THREE DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4).
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Patient 1
THE INVESTIGATION DETERMINED THAT NON-REPRODUCIBLE VITROS GENT RESULTS WERE OBTAINED ON THREE DIFFERENT QUALITY CONTROL FLUIDS PROCESSED ON A VITROS 5,1FS CHEMISTRY SYSTEM. THE MOST LIKELY CAUSE FOR THIS EVENT IS RELATED TO VITROS GENT REAGENT LOT 1512-09-3511, AS NON-REPRODUCIBLE LOWER THAN EXPECTED RESULTS WERE OBTAINED USING THREE PARTICULAR REAGENT PACKS FROM LOT 1512-09-3511. THERE IS NO INDICATION THAT THE VITROS 5,1FS INSTRUMENT ISSUE CONTRIBUTED TO THE EVENT. THE ASSIGNABLE CAUSE FOR THE EVENT IS RELATED TO VITROS GENT REAGENT LOT 1512-09-3511.