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Patient 1
THE INVESTIGATION CONFIRMED THAT LOWER THAN EXPECTED VITROS VANC (VANCOMYCIN) AND VITROS VALP (VALPROIC ACID) RESULTS WERE OBTAINED FROM TWO PATIENT SAMPLES AND ON TWO LEVELS OF NON-VITROS (BIORAD) QUALITY CONTROL (QC) FLUIDS ON A VITROS 4600 CHEMISTRY SYSTEM. THE INVESTIGATION WAS ABLE TO DETERMINE THE ASSIGNABLE CAUSE FOR THE LOWER THAN EXPECTED VITROS VANC AND VALP RESULTS WERE THE REAGENT PACKS IN USE AT THE TIME OF THE EVENT. THE LOWER THAN EXPECTED RESULTS WERE OBTAINED FROM A SINGLE PACK OF VITROS VANC REAGENT AND A SINGLE PACK OF VITROS VALP REAGENT. EXPECTED RESULTS WERE OBTAINED AFTER A NEW, UNUSED PACK OF VITROS VANC AND A NEW, UNUSED PACK OF VITROS VALP WERE PLACED ON THE INSTRUMENT. ALTHOUGH PROPER REAGENT HANDLING FOR BOTH VITROS VANC AND VITROS VALP WAS VERIFIED, IMPROPER PACK HANDLING CANNOT BE RULED OUT AS A POSSIBLE CAUSE OF THIS EVENT. THE ASSIGNABLE CAUSE OF WHAT AFFECTED THE REAGENT PACKS IN USE AT THE TIME OF THE EVENTS COULD NOT BE DETERMINED. A DIAGNOSTIC WITHIN RUN VITROS GENT (GENTAMICIN) PRECISION TEST WAS WITHIN ORTHO GUIDELINES BOTH PRE AND POST SERVICE INDICATING THE VITROS 4600 CHEMISTRY SYSTEM WAS PERFORMING AS EXPECTED. AN INSTRUMENT RELATED ISSUE CAN BE RULED OUT AS A CONTRIBUTING FACTOR TO THE EVENT. HISTORICAL QC RESULTS INDICATE THAT VITROS VANC LOT 2514-37-6935 AND VITROS VALP LOT 2511-26-6892 ARE PERFORMING AS INTENDED. A TRANSIENT ISSUE RELATED TO THE REAGENT PERFORMANCE CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR. CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD POINT TO A POTENTIAL SYSTEMIC ISSUE WITH VITROS VANC LOT 2514 37 6935 OR VITROS VALP LOT 2511 26 6892.