THE INVESTIGATION DETERMINED THAT HIGHER THAN EXPECTED VITROS NA+ AND VITROS K+ RESULTS WERE ATTAINED FROM A NON-VITROS QUALITY CONTROL (QC) FLUID PROCESSED USING VITROS CHEMISTRY PRODUCTS NA+ SLIDES AND VITROS CHEMISTRY PRODUCTS K+ SLIDES IN COMBINATION WITH A VITROS 5600 INTEGRATED SYSTEM. THE EVENT WAS ISOLATED TO THE CALIBRATION EVENT PERFORMED ON (B)(6) 2018. THE CALIBRATIONS WERE SUBOPTIMAL WHEN COMPARED TO THE TYPICAL CALIBRATION RESPONSES AND PARAMETERS, AND AS SHOWN BY THE HIGH RECOVERY OF THE POST CALIBRATION QUALITY CONTROL RESULTS. THE VITROS CALIBRATION KIT IN USE FOR BOTH CALIBRATION EVENTS WAS VITROS CAL KIT 267. THE MOST LIKELY CAUSE OF THE SUBOPTIMAL CALIBRATION IS USER ERROR, WHERE IMPROPER RECONSTITUTION OF CALIBRATORS OR IMPROPER SAMPLE HANDLING OCCURRED, ALTHOUGH THIS COULD NOT BE CONFIRMED. ACCEPTABLE VITROS NA+ AND K+ PERFORMANCE WAS OBSERVED AFTER ADDITIONAL CALIBRATION EVENTS WERE PERFORMED USING PROPERLY HANDLED CALIBRATOR FLUIDS. THE INVESTIGATION FOUND NO INDICATION THAT THE VITROS 5600 INTEGRATED SYSTEM OR VITROS NA+ SLIDE LOT 4219-0990-0261 OR VITROS K+ SLIDE LOT 4102-0991-8560 CONTRIBUTED TO THE EVENT.
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Patient 1
A CUSTOMER OBTAINED HIGHER THAN EXPECTED VITROS NA+ AND VITROS K+ RESULTS FROM A NON-VITROS QUALITY CONTROL (QC) FLUID PROCESSED USING VITROS CHEMISTRY PRODUCTS NA+ SLIDES AND VITROS CHEMISTRY PRODUCTS K+ SLIDES IN COMBINATION WITH A VITROS 5600 INTEGRATED SYSTEM. BIORAD L1 NA+ RESULT OF 194.8 MMOL/L VS. THE EXPECTED RESULT OF 120.0 MMOL/L. BIORAD L1 K+ RESULT OF 4.50 MMOL/L VS. THE EXPECTED RESULT OF 2.55 MMOL/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 NA+ AND VITROS K+ RESULTS WERE OBTAINED FROM A QC FLUID AND WERE NOT REPORTED FROM THE LABORATORY. THERE WERE NO ALLEGATIONS OF PATIENT HARM AS A RESULT OF THE EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBERS (B)(4).