VITROS CHEMISTRY PRODUCTS GLU SLIDES

Description of Event or Problem

A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS GLU RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF VITROS PERFORMANCE VERIFIER (PV) II, LOT X1901, FLUID TESTED USING VITROS GLUCOSE (GLU) SLIDE LOT 0035-247-5207 ON A VITROS 350 CHEMISTRY SYSTEM. THE LOWER THAN EXPECTED VITROS GLU RESULTS WERE GENERATED FROM CALIBRATIONS USING CALIBRATION (CAL) KIT I, LOT 0114. VITROS PERFORMANCE VERIFIER (PV) II VITROS GLU RESULTS OF 100.9 AND <10.0 MG/DL VS. THE EXPECTED RESULT OF 287.3 MG/DL 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 GLU RESULTS WERE OBTAINED FROM NON-PATIENT QUALITY CONTROL SAMPLES. HOWEVER, THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLES WERE NOT 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 TWO OF TWO 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWO DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

Additional Manufacturer Narrative

THE INVESTIGATION DETERMINED THAT LOWER THAN EXPECTED VITROS GLU RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF VITROS PERFORMANCE VERIFIER (PV) II, LOT X1901, FLUID TESTED USING VITROS GLUCOSE (GLU) SLIDE LOT 0035-247-5207 ON A VITROS 350 CHEMISTRY SYSTEM. THE LOWER THAN EXPECTED VITROS GLU RESULTS WERE GENERATED FROM CALIBRATIONS USING CALIBRATION (CAL) KIT I, LOT 0114. THE ASSIGNABLE CAUSE OF THE EVENT COULD NOT BE CONFIRMED WITH THE INFORMATION PROVIDED. THE LOWER THAN EXPECTED VITROS GLU RESULTS WERE OBTAINED FROM CALIBRATIONS PERFORMED USING CAL KIT I, LOT 0114 CALIBRATORS THAT HAD ATYPICAL CALIBRATION RESPONSES AND PARAMETERS WHEN COMPARED TO THE EXPECTED RESPONSES AND PARAMETERS. ACCEPTABLE VITROS GLU RESULTS WERE OBTAINED FROM A CALIBRATION GENERATED FROM VITROS CAL KIT I, LOT 0214, HOWEVER, THE CUSTOMER DID NOT PROVIDE THE CALIBRATION DATA AND IT IS UNKNOWN IF THE CALIBRATION RESPONSES AND PARAMETERS WERE TYPICAL WHEN COMPARED TO THE EXPECTED RESPONSES AND PARAMETERS. IN ADDITION, IT IS UNKNOWN IF THE CUSTOMER TESTED THE SAME VIAL OF VITROS PV II, LOT X1901 AS WAS USED WHEN THE LOWER THAN EXPECTED RESULTS WERE OBTAINED, OR IF A SECOND VIAL WAS RECONSTITUTED. THEREFORE, IT CANNOT BE DETERMINED IF THE EVENT WAS RESOLVED BY USING A NEW VIAL OF VITROS PV II, LOT X1901 FLUID, OR BY CALIBRATING WITH AN ALTERNATE LOT OF CALIBRATOR. NO HISTORICAL QUALITY CONTROL RESULTS OBTAINED FROM VITROS GLU SLIDE LOT 0035-3247-5207 USING THE VITROS PV FLUIDS WAS PROVIDED, THEREFORE, A PERFORMANCE ISSUE WITH VITROS GLU SLIDE LOT 0035- 3247-5207 CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT. CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD POINT TO A POTENTIAL SYSTEMIC PERFORMANCE ISSUE WITH VITROS GLU SLIDE LOT 0035-3247-5207. THE CUSTOMER STATED THE VITROS CAL KIT I, LOT 0114 WAS RECONSTITUTED USING A FIXED 3 ML PIPETTE. NO INFORMATION WAS PROVIDED CONCERNING WHEN THE FIXED 3 ML PIPETTE WAS LAST CALIBRATED. IN ADDITION, THE DATE THE CALIBRATOR FLUIDS WERE RECONSTITUTED AND HOW THE CALIBRATOR FLUIDS WERE STORED WAS NOT PROVIDED. THE VITROS CAL KIT I INSTRUCTIONS FOR USE STATES THE CALIBRATOR KIT I VIALS SHOULD BE RECONSTITUTED USING A 3 ML VOLUMETRIC PIPETTE, AND THE RECONSTITUTED FLUIDS SHOULD BE USED WITHIN 24 HOURS. THEREFORE, A PERFORMANCE ISSUE WITH THE VITROS CAL KIT I, LOT 0114 FLUIDS IN USE, DUE TO IMPROPER FLUID HANDLING, CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT. A PERFORMANCE ISSUE WITH THE VITROS 350 CHEMISTRY SYSTEM DID NOT LIKELY CONTRIBUTE TO THE EVENT AS ACCEPTABLE PERFORMANCE WAS OBTAINED USING A CALIBRATION WITH TYPICAL RESPONSES AND PARAMETERS, WITHOUT TAKING ANY ACTIONS TO OPTIMIZE THE VITROS 350 CHEMISTRY SYSTEM.