VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1

Additional Manufacturer Narrative

THE INVESTIGATION DETERMINED THAT LOWER THAN EXPECTED VITROS LACTATE (LAC) RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF NON-VITROS BIORAD MULTIQUAL UNASSAYED CONTROLS, LOT 45980, AND A SINGLE LEVEL OF VITROS PERFORMANCE VERIFIER (PV) FLUID USING VITROS LAC SLIDE LOT 3533-0131-6128 TESTED ON A VITROS XT7600 INTEGRATED SYSTEM. THE ASSIGNABLE CAUSE OF THE LOWER THAN EXPECTED RESULTS WAS SUBOPTIMAL CALIBRATIONS OBTAINED FROM VITROS CALIBRATOR KIT 1, LOT 0145. THE CAUSE OF THE SUBOPTIMAL CALIBRATIONS IS UNKNOWN. THE CUSTOMER DID NOT PROVIDE ANY ADDITIONAL DETAILS SUCH AS THAW TIME, MIXING TECHNIQUES, INFORMATION ABOUT RECONSTITUTION OR ROOM TEMPERATURE EQUILIBRATION TIME. THEREFORE, IMPROPER FLUID HANDLING OF THE CALIBRATOR FLUIDS CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT. ACCEPTABLE VITROS LAC PERFORMANCE WAS OBTAINED USING AN ALTERNATE CALIBRATION EVENT THAT WAS GENERATED USING A NEW SET OF VITROS CALIBRATOR KIT 0145. THIS INDICATED NEITHER VITROS LAC SLIDE LOT 3533-0131-6128 NOR THE VITROS XT7600 INTEGRATED SYSTEM LIKELY CONTRIBUTED TO THE EVENT. CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD POINT TO A POTENTIAL SYSTEMIC ISSUE WITH VITROS LAC SLIDE LOT 3533-0131-6128.

Description of Event or Problem

A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS LACTATE (LAC) RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF NON-VITROS BIORAD MULTIQUAL UNASSAYED CONTROLS, LOT 45980, AND A SINGLE LEVEL OF VITROS PERFORMANCE VERIFIER (PV) FLUID USING VITROS LAC SLIDE LOT 3533-0131-6128 TESTED ON A VITROS XT7600 INTEGRATED SYSTEM. BIORAD LEVEL 2 VITROS LAC RESULTS OF 2.66, 2.53, 2.63, 2.71, 2.54, 2.52 AND 2.55 MMOL/L VS. THE BASELINE MEAN VALUE OF 3.22 MMOL/L VITROS PV II, LOT D2338 VITROS LAC RESULTS OF 2.71 AND 2.87 MMOL/L VS. THE RANGE OF MEANS MIDPOINT VALUE OF 3.76 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 LOWER-THAN-EXPECTED VITROS LAC RESULTS WERE OBTAINED FROM NON-PATIENT QUALITY CONTROL FLUIDS. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THE EVENT. THIS REPORT IS NUMBER ONE OF FOUR MDRS FOR THIS EVENT. FOUR 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS FOUR DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).