THE INVESTIGATION DETERMINED THAT HIGHER AND LOWER THAN EXPECTED RESULTS WERE OBTAINED FROM TWO DIFFERENT LEVELS OF NON-VITROS BIORAD CONTROLS AND A SINGLE LEVEL OF VITROS TDM PV FLUID USING TWO DIFFERENT VITROS VALP REAGENT LOTS ON A VITROS 5,1 FS SYSTEM. THE MOST LIKELY ASSIGNABLE CAUSE IS AN INSTRUMENT RELATED EVENT. A VITROS GENT WITHIN-RUN PRECISION TEST, USED TO ASSESS INSTRUMENT PERFORMANCE, WAS OUTSIDE OF ACCEPTABLE GUIDELINES, INDICATING THE VITROS 5,1 FS SYSTEM WAS NOT PERFORMING AS INTENDED. AN ORTHO FIELD ENGINEER PERFORMED A RESET OF THE BELT TENSION FOR SECONDARY METERING, PERFORMED ALL SECONDARY METERING ADJUSTMENTS, AND PERFORMED THE X-ARM AT READ ADJUSTMENT FOR READING THE CUVETTE IN THE PHOTOMETER. A POST SERVICE VITROS GENT WITHIN-RUN PRECISION TEST WAS WITHIN ACCEPTABLE GUIDELINES; HOWEVER, ALL VITROS VALP RESULTS WERE LOWER THAN EXPECTED AFTER SERVICE. ACCEPTABLE PERFORMANCE WAS OBTAINED AFTER THE CUSTOMER PERFORMED THE ROUTINE MAINTENANCE PROCEDURES OF REPLACING THE PHOTOMETER LAMP, PERFORMING A WATER BLANK AND RECALIBRATING VITROS VALP REAGENT LOT 2511-25-5727.
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Patient 1
A CUSTOMER OBSERVED HIGHER AND LOWER THAN EXPECTED RESULTS FROM TWO DIFFERENT LEVELS OF NON-VITROS BIORAD CONTROLS AND A SINGLE LEVEL OF VITROS TDM PV FLUID USING TWO DIFFERENT VITROS VALP REAGENT LOTS ON A VITROS 5,1 FS SYSTEM. VITROS VALP REAGENT LOT 2511-25-5263. BIORAD L1 LOT 40901 VALP RESULT OF 150, >150, 83.3, 129.5, 130.6, 130.0, 128.6, AND 134.8 UG/ML VS. THE EXPECTED RESULT OF 106.6 UG/ML. VITROS VALP REAGENT, LOT 2511-25-5727. BIORAD L1 LOT 40901 VALP RESULT OF 24.0 UG/ML VS. THE EXPECTED RESULT OF 34.4 UG/ML VITROS TDM PV R5895 RESULT OF 52.1 UG/ML VS. THE EXPECTED RESULT OF 65.6 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. THE CUSTOMER MADE NO ALLEGATIONS THAT PATIENT SAMPLES WERE AFFECTED AND THERE WERE NO REPORTED ALLEGATIONS OF ACTUAL PATIENT HARM AS A RESULT OF THIS EVENT. HOWEVER, THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLE RESULTS WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS (ORTHO) INC. COMPLAINT NUMBERS 1936421 AND 1939004 / IVD 414239.