THE INVESTIGATION DETERMINED THAT LOWER THAN EXPECTED MYOGLOBIN RESULTS WERE OBTAINED FROM TWO LEVELS OF BIORAD QUALITY CONTROL FLUIDS PROCESSED USING VITROS MYOGLOBIN REAGENT ON A VITROS 5600 INTEGRATED SYSTEM. THE MOST LIKELY ASSIGNABLE CAUSE IS INSTRUMENT RELATED. A REVIEW OF HISTORICAL BIORAD QC FLUID PERFORMANCE ACROSS TWO VITROS 5600 SYSTEMS IN THE LABORATORY CONCLUDED THAT MYOGLOBIN IMPRECISION WAS OCCURRING ON ONLY ONE VITROS SYSTEM SUGGESTING THAT THE ISSUE IS MOST LIKELY INSTRUMENT AND NOT REAGENT RELATED. AN ORTHO FIELD ENGINEER PERFORMED SERVICE ACTIONS THAT INCLUDE REPLACEMENT OF THE REAGENT METERING PROBE AND ADJUSTMENTS IN SEVERAL SUBSYSTEMS. FOLLOWING THESE ACTIONS, ACCEPTABLE WITHIN RUN MYOGLOBIN PRECISION RESULTS WERE OBTAINED. IN ADDITION, ACCEPTABLE BIORAD QC PERFORMANCE WAS MAINTAINED INDICATING THE VITROS 5600 SYSTEM WAS PERFORMING AS EXPECTED FOLLOWING SERVICE ACTIONS.
D
Patient 1
THE INVESTIGATION DETERMINED THAT LOWER THAN EXPECTED MYOGLOBIN RESULTS WERE OBTAINED FROM TWO LEVELS OF NON-VITROS BIORAD LOT 23630 QUALITY CONTROL FLUIDS PROCESSED USING VITROS IMMUNODIAGNOSTICS PRODUCTS MYOGLOBIN REAGENT LOT 1210 ON A VITROS 5600 INTEGRATED SYSTEM. BIORAD LEVEL 1= 101.4, 89.63, 113.46, 110.188, 116.413, 113.041, 118.559, 78.998, 82.18, 109.92, 116.995, 95.58, 93.59, 96.5, 96.312, 82.75, 84.98 AND 96.67 NG/ML VERSUS EXPECTED 131 NG/ML. BIORAD LEVEL 2= 0.90 AND 91.096 NG/ML VERSUS EXPECTED 251 NG/ML. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE UNEXPECTED VITROS MYOGLOBIN RESULTS WERE GENERATED FROM NON-PATIENT FLUIDS, HOWEVER THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLE RESULTS WERE NOT AFFECTED AND WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THE EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBER (B)(4).