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Patient 1
THE INVESTIGATION CONCLUDED THAT HIGHER AND LOWER THAN EXPECTED RESULTS WERE OBTAINED FROM THREE DIFFERENT LEVELS OF VITROS TDM PV QUALITY CONTROL FLUIDS USING VITROS VALP REAGENT, ON A VITROS 5,1 FS CHEMISTRY SYSTEM. THE ASSIGNABLE CAUSE OF THE HIGHER THAN EXPECTED VITROS VALP RESULTS OBTAINED USING VITROS TDM PV FLUIDS WAS DETERMINED TO BE CALIBRATION RELATED. THE RESPONSES AND PARAMETERS OF THE AFFECTED CALIBRATION APPEARED ATYPICAL TO EXPECTED RESPONSES AND PARAMETERS. RECALIBRATING WITH AN ALTERNATE SET OF CALIBRATORS FROM THE SAME LOT HAD RESOLVED THE ISSUE. THE DEFINITIVE ASSIGNABLE CAUSE OF THE LOWER THAN EXPECTED VITROS TDM PV FLUID RESULTS WAS UNKNOWN, HOWEVER, PRE-ANALYTICAL SAMPLE MIX UP AND IMPROPER FLUID HANDLING PROTOCOL COULD NOT BE RULED OUT AS CONTRIBUTING FACTORS TO THE EVENT. WITHIN-RUN PRECISION TESTING USED TO ASSESS INSTRUMENT PERFORMANCE WAS NOT PERFORMED AND THEREFORE AN INSTRUMENT ISSUE CANNOT BE RULED OUT AS A POTENTIAL CONTRIBUTOR. ACCEPTABLE RESULTS WERE OBTAINED FROM THE SAME REAGENT PACKS THAT INITIALLY GENERATED LOWER THAN EXPECTED RESULTS. ONGOING TRACKING AND TRENDING OF COMPLAINT DATA HAS NOT IDENTIFIED ANY SIGNALS TO SUGGEST THERE IS A SYSTEMIC QUALITY ISSUE WITH VITROS VALP REAGENT LOT 2511-25-6393. THEREFORE, A VITROS VALP REAGENT RELATED ISSUE DID NOT LIKELY CONTRIBUTE TO THE EVENT.