VITROS IMMUNODIAGNOSTIC PRODUCTS NT-PROBNP II REAGENT PACK

Additional Manufacturer Narrative

THE INVESTIGATION DETERMINED THAT LOWER THAN EXPECTED VITROS NT PRO-BNP II (NBNP2) RESULTS WERE OBTAINED FROM A VITROS RANGE VERIFIER (RV) 2 FLUID, LOT 0080 USING REAGENT LOT 0096 TESTED ON A VITROS 5600 INTEGRATED SYSTEM. THE ASSIGNABLE CAUSE OF THE EVENT COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. A SUBOPTIMAL CALIBRATION CANNOT BE COMPLETELY RULED OUT AS CONTRIBUTING TO THE EVENT AS ACCEPTABLE PERFORMANCE WAS OBTAINED AFTER RECALIBRATING VITROS NBNP2 REAGENT LOT 0096. HOWEVER, THE INITIAL CALIBRATION FROM WHICH THE LOWER THAN EXPECTED RESULTS WERE OBTAINED DID NOT APPEAR ATYPICAL WHEN COMPARED TO THE EXPECTED ¿FITTED¿ SIGNAL SET BY ORTHO AND POST CALIBRATION QUALITY CONTROL RESULTS WERE ACCEPTABLE. A REAGENT RELATED PERFORMANCE ISSUE DID NOT LIKELY CONTRIBUTE TO THE EVENT, AS POST CALIBRATION QUALITY CONTROL RESULTS INDICATED VITROS NBNP2 REAGENT LOT 0096 WAS PERFORMING AS INTENDED. IN ADDITION, CONTINUAL TRACKING AND TRENDING DID NOT INDICATE A PERFORMANCE ISSUE WITH VITROS NBNP2 REAGENT LOT 0096. THE VITROS RV 2 FLUID RESULTS WERE NEGATIVELY BIASED BY APPROXIMATELY 59%. VITROS RV FLUIDS ARE LIQUID, READY TO USE. THE ORTHO TSC QUESTIONED IF THE CUSTOMER HAD INADVERTENTLY DILUTED THE RV FLUIDS, THINKING THE FLUIDS REQUIRED RECONSTITUTION. THE CUSTOMER DID NOT CONFIRM OR DENY THE RV FLUIDS WERE IMPROPERLY DILUTED; THEREFORE, IMPROPER SAMPLE HANDLING CANNOT BE COMPLETELY RULED OUT AS CONTRIBUTING TO THE EVENT. THERE WAS NO INDICATION THE VITROS 5600 INTEGRATED SYSTEM WAS NOT PERFORMING AS INTENDED, HOWEVER, SINCE NO DIAGNOSTIC PRECISION TESTING WAS PERFORMED TO ASSESS INSTRUMENT PERFORMANCE, AN INSTRUMENT RELATED PERFORMANCE ISSUE CANNOT BE COMPLETELY RULED OUT AS CONTRIBUTING THE EVENT.

Description of Event or Problem

A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS NT PRO-BNP II (NBNP2) RESULTS WERE OBTAINED FROM A VITROS RANGE VERIFIER 2 FLUID, LOT 0080 USING REAGENT LOT 0096 TESTED ON A VITROS 5600 INTEGRATED SYSTEM. VITROS RANGE VERIFIER 2 RESULTS OF 11946 AND 11819 PG/ML VS. THE TARGET VALUE OF 29400 PG/ML. 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 RESULTS WERE ISOLATED TO NON-PATIENT SAMPLES, THE CUSTOMER MADE NO INDICATION THAT PATIENT SAMPLE RESULTS WERE AFFECTED. THERE WERE NO REPORTED ALLEGATIONS OF PATIENT HARM. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT 601835.