THE INVESTIGATION DETERMINED THAT 3 LOWER THAN EXPECTED VITROS AMON RESULTS WERE OBTAINED FROM A VITROS QUALITY CONTROL FLUID USING VITROS AMON SLIDE LOTS 1017-0245-0209 AND 1014-0247-3348, TESTED ON A VITROS 5600 INTEGRATED SYSTEM S/N (B)(4). THE MOST LIKELY ASSIGNABLE CAUSE OF THE LOWER THAN EXPECTED VITROS AMON QUALITY CONTROL RESULTS IS AN INSTRUMENT PERFORMANCE ISSUE, AS A WITHIN-RUN VITROS AMON PRECISION TEST WAS OUTSIDE PERFORMANCE GUIDELINES, INDICATING THAT THE VITROS 5600 INTEGRATED SYSTEM WAS NOT PERFORMING AS INTENDED. FOLLOWING SERVICE ACTIONS WHICH INCLUDED INCUBATOR CLEANING AND REPLACEMENT OF THE INCUBATOR EVAPORATION CAPS THE POST-SERVICE PRECISION TEST RESULTS WERE SIGNIFICANTLY IMPROVED, INDICATING SERVICE ACTIONS HAD RETURNED THE VITROS 5600 SYSTEM TO EXPECTED PERFORMANCE.
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A CUSTOMER REPORTED IMPRECISE QUALITY CONTROL RESULTS (QC) USING VITROS CLINICAL CHEMISTRY PRODUCTS AMMONIA (AMON) SLIDES ON A VITROS 5600 INTEGRATED SYSTEM. VITROS LIQUID PERFORMANCE VERIFIER (LOT A5363) RESULTS OF 139.7, 137.3 AND 153.2 UMOL/L VERSUS AN EXPECTED RESULT OF 192.3 UMOL/L. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF PATIENT SAMPLES WERE AFFECTED. ALTHOUGH THERE WERE NO REPORTS OF AFFECTED PATIENT SAMPLE RESULTS, IT CANNOT BE CONFIRMED THAT PATIENT SAMPLE RESULTS WERE NOT AFFECTED OR WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBER (B)(4)/QERTS RECORD ID (B)(4).