THE INVESTIGATION DETERMINED LOWER THAN EXPECTED VITROS PHYT RESULTS WERE OBTAINED FROM VITROS AND NON-VITROS QUALITY CONTROL FLUIDS, USING TWO DIFFERENT SLIDE LOTS OF VITROS PHYT SLIDES TESTED ON A VITROS 5600 INTEGRATED SYSTEM. A DEFINITIVE ASSIGNABLE CAUSE COULD NOT BE DETERMINED, HOWEVER, A SUB-OPTIMAL CALIBRATION DUE TO IMPROPER FLUID HANDLING CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT. THE HIGHER THAN EXPECTED QUALITY CONTROL RESULTS WERE OBTAINED USING MULTIPLE CALIBRATION EVENTS WHERE THE CALIBRATOR SIGNALS WITHIN ACCEPTABLE LIMITS, HOWEVER, THE CALIBRATOR 3 SIGNALS WERE HIGHER THAN THE EXPECTED SIGNALS ON ALL CALIBRATION EVENTS REVIEWED. THIS CAUSED THE CURVATURE PARAMETER TO BE ELEVATED. CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT POINT TO A POTENTIAL SYSTEMIC ISSUE WITH VITROS PHYT SLIDE LOT 2617-0167-0905. MULTIPLE LOTS OF VITROS CALIBRATOR KIT 9 WERE USED, THEREFORE, IT IS UNLIKELY THE CALIBRATOR KIT LOT CONTRIBUTED TO THE EVENT. VITROS CALIBRATOR KIT 9 IS LIQUID, READY TO USE, THAT IS STORED FROZEN. IT IS POSSIBLE IMPROPER FLUID HANDLING, IN REGARDS TO FLUID TEMPERATURE, CONTRIBUTED TO THE EVENT, HOWEVER, THIS WAS NOT CONFIRMED.
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Patient 1
A CUSTOMER REPORTED MULTIPLE HIGHER THAN EXPECTED VITROS PHYT QUALITY CONTROL RESULTS WERE OBTAINED USING TWO DIFFERENT LEVELS OF NON-VITROS BIORAD QUALITY CONTROL (QC) FLUIDS AND A SINGLE VITROS TDM QC FLUID TESTED ON A VITROS 5600 INTEGRATED SYSTEM. VITROS TDM PV III LOT X6157 RESULT OF 29.34 UG/ML VERSUS THE EXPECTED RESULT OF 24.3 UG/ML BIORAD LOT 31870 L1 RESULTS OF 14.40, 14.62 AND 18.52 UG/ML VS. THE EXPECTED RESULT OF 12.0 UG/ML. BIORAD LOT 31870 L3 RESULTS OF 26.85, 27.76, 27.74, 26.60, 26.48, 26.74, 27.47, 29.43, 26.44, 27.55, 27.12, 27.86, 26.58, 26.14, 28.77, 27.73, 27.67, AND 26.47 UG/ML VS. THE EXPECTED RESULT OF 22.0 UG/ML. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THE EVENT WERE TO OCCUR UNDETECTED. THE CUSTOMER MADE NO ALLEGATION THAT PATIENT RESULTS WERE AFFECTED OR REPORTED FROM THE LABORATORY; HOWEVER, THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLES 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 IS NUMBER FIFTEEN (15) OF TWENTY ONE (21) MDR?S FOR THIS EVENT, AS TWENTY ONE 3500A FORMS ARE BEING SUBMITTED AS TWENTY ONE DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBER (B)(4).