VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 5

Additional Manufacturer Narrative

THE INVESTIGATION DETERMINED THAT HIGHER THAN EXPECTED VITROS AMMONIA (AMON) RESULTS WERE OBTAINED FROM A NON-VITROS BIORAD QUALITY CONTROL FLUID PROCESSED USING VITROS CHEMISTRY PRODUCTS AMON SLIDES LOT 1019-0259-0222 ON A VITROS 5600 INTEGRATED SYSTEM. THE ASSIGNABLE CAUSE OF THE HIGHER THAN EXPECTED VITROS AMON RESULTS IS A SUBOPTIMAL CALIBRATION. THE PARAMETERS OF THE CALIBRATION USED TO OBTAIN THE RESULTS WERE DETERMINED TO BE ATYPICAL WHEN COMPARED TO THE DATABASE VALUES. ACCEPTABLE RESULTS WERE OBTAINED AFTER A RECALIBRATION EVENT. THE CAUSE OF THE SUBOPTIMAL CALIBRATION IS UNKNOWN. HOWEVER, A POSSIBLE CAUSE OF THE SUBOPTIMAL CALIBRATION IS IMPROPER PROTOCOL AS THE CUSTOMER COULD NOT CONFIRM IF THE VITROS CAL KIT 5 FLUIDS USED FOR THE SUBOPTIMAL CALIBRATION HAD BEEN ADEQUATELY BROUGHT TO ROOM TEMPERATURE PRIOR TO BEING PROCESSED ON THE VITROS 5600 SYSTEM AS REQUIRED. FOLLOWING A RECALIBRATION USING FRESH VIALS OF VITROS CAL KIT 5, VITROS AMON RESULTS RETURNED TO EXPECTATIONS USING THE BIORAD CONTROL FLUIDS. BASED ON HISTORICAL QUALITY CONTROL RESULTS, A VITROS AMON LOT 1019-0259-0222 IS NOT A LIKELY CONTRIBUTOR OF THE EVENT. ADDITIONALLY, CONTINUAL TRACKING AND TRENDING OF COMPLAINT DATA HAS NOT IDENTIFIED ANY SIGNALS TO SUGGEST THERE IS A SYSTEMIC QUALITY ISSUE WITH VITROS AMON REAGENT LOT 1019-0259-0222. ALTHOUGH PRECISION TESTING WAS NOT PERFORMED ON THE VITROS 5600 INTEGRATED SYSTEM AN INSTRUMENT RELATED ISSUE IS NOT A LIKELY CONTRIBUTOR OF THE EVENT AS QUALITY CONTROL RESULTS WERE RETURNED TO EXPECTATIONS AFTER A RECALIBRATION EVENT WITHOUT ANY KNOWN TROUBLESHOOTING ACTIONS BEING PERFORMED ON THE INSTRUMENT.

Description of Event or Problem

A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS AMMONIA (AMON) RESULTS WERE OBTAINED FROM A NON-VITROS BIORAD QUALITY CONTROL FLUID PROCESSED USING VITROS CHEMISTRY PRODUCTS AMON SLIDES LOT 1019-0259-0222 ON A VITROS 5600 INTEGRATED SYSTEM. BIORAD CONTROL LOT 54360 LEVEL 2 VITROS AMON RESULTS OF 126.9, 123.0 AND 120.8 UMOL/L VERSUS AN EXPECTED RESULT OF 93.1 UMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE HIGHER THAN EXPECTED VITROS AMON RESULTS WERE OBTAINED WHEN PROCESSING A CONTROL FLUID. NO RESULTS WERE REPORTED OUT OF THE LABORATORY AND THE CUSTOMER MADE NO INDICATION THAT PATIENT SAMPLE RESULTS WERE AFFECTED OR QUESTIONED. ORTHO WAS NOT MADE AWARE OF ANY ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).