VITROS CHEMISTRY PRODUCTS LAC SLIDES

Description of Event or Problem

A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED LACTATE RESULTS OBTAINED FROM PATIENT SAMPLES DURING A REAGENT LOT TO LOT CORRELATION USING VITROS CHEMISTRY PRODUCTS LAC SLIDES LOT 3533-0136-3396 ON A VITROS XT 7600 INTEGRATED SYSTEM. PATIENT 5 RESULT OF 2.9 MMOL/L VS AN EXPECTED RESULT OF 2.3 MMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE HIGHER-THAN-EXPECTED VITROS LAC RESULT WAS OBTAINED DURING A REAGENT LOT TO LOT CORRELATION AND WAS NOT REPORTED FROM THE LABORATORY. THERE HAS BEEN NO 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 614551.

Additional Manufacturer Narrative

THE INVESTIGATION HAS DETERMINED THAT HIGHER THAN EXPECTED LACTATE RESULTS OBTAINED FROM PATIENT SAMPLES PROCESSED DURING A REAGENT LOT TO LOT CORRELATION USING VITROS CHEMISTRY PRODUCTS LAC SLIDES LOT 3533-0136-3396 ON A VITROS XT 7600 INTEGRATED SYSTEM. A DEFINITIVE ASSIGNABLE CAUSE OF THE EVENT COULD NOT BE DETERMINED. BASED ON QUALITY CONTROL RESULTS A VITROS LAC REAGENT LOT 3533-0130-3396 RELATED ISSUE IS NOT A LIKELY CONTRIBUTING FACTOR 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 LAC REAGENT LOT 3533-0130-3396. VITROS PERFORMANCE VERIFIER RESULTS WERE WITHIN EXPECTATIONS VERIFYING THE CALIBRATION PARAMETERS FOR VITROS LAC REAGENT LOT 3533-0130-3396 INDICATING THAT A SUBOPTIMAL CALIBRATION IS NOT A LIKELY CONTRIBUTOR OF THE EVENT. NO PRECISION TESTING WAS PERFORMED ON THE VITROS XT 7600 INTEGRATED SYSTEM AND THEREFORE, AN INSTRUMENT RELATED ISSUE CANNOT BE RULED OUT AS A CONTRIBUTOR OF THE EVENT. HOWEVER, THERE WAS NO EVIDENCE OF AN INSTRUMENT MALFUNCTION. PRE-ANALYTICAL SAMPLE PROCESSING COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR AS THE CUSTOMER WAS NOT FOLLOWING THE SAMPLE COLLECTION DEVICE MANUFACTURER RECOMMENDED CENTRIFUGATION PROTOCOL. IMPROPER PRE-ANALYTICAL SAMPLE HANDLING COULD HAVE CONTRIBUTED TO THE EVENT. IT IS POSSIBLE THAT CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, WAS PRESENT IN THE AFFECTED SAMPLE, ALTHOUGH THIS COULD NOT BE CONFIRMED. THE TIME BETWEEN TESTING EVENTS CANNOT BE RULED OUT AS A CONTRIBUTOR OF THE EVENT AS THE PATIENT SAMPLES WERE TESTING USING VITROS LAC LOT 3533-0130-3396 APPROXIMATELY 4 TO 5 HOURS AFTER INITIALLY BEING TESTED ON THE ALTERNATE VITROS LAC REAGENT LOT WHICH IS ACCEPTABLE PER THE VITROS LAC IFU GUIDELINES, WHICH STATES SAMPLES ARE STABLE WHEN STORED FOR <OR=8 HOURS AT ROOM TEMPERATURE (64-82 DEGREES F). HOWEVER, IT IS UNKNOWN IF THE LABORATORY TEMPERATURE WAS WITHIN THIS RANGE AT THE TIME OF TESTING. THE CUSTOMER LATER TESTED TWO ADDITIONAL PATIENT SAMPLES USING BOTH REAGENT LOTS AT THE SAME APPROXIMATE TIME AND THE RESULTS WERE CONCORDANT AND ACCEPTABLE.