VITROS IMMUNODIAGNOSTIC PRODUCTS NT-PROBNP II REAGENT PACK

Additional Manufacturer Narrative

THE INVESTIGATION CONCLUDES THAT A LOWER THAN EXPECTED VITROS NT-PROBNP II (NBNP2) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE TESTED AS A LOT TO LOT CORRELATION WHEN PUTTING VITROS NBNP2 REAGENT LOT 2131 INTO USE ON A VITROS 5600 INTEGRATED SYSTEM. THE ASSIGNABLE CAUSE OF THE EVENT WAS SUBOPTIMAL CALIBRATION, ALTHOUGH NO CALIBRATION DATA WAS PROVIDED. THE ORTHO FIELD APPLICATION SPECIALIST STATED THAT THE LEVEL 3 CALIBRATOR FLUID WAS CONTAMINATED, HOWEVER NO DETAILS REGARDING THE TYPE OF CONTAMINATION WERE PROVIDED. IN ORDER TO DETERMINE IF THE VITROS 5600 SYSTEM WAS PERFORMING AS INTENDED, THE TSC REQUESTED THE CUSTOMER PERFORM A DIAGNOSTIC VITROS TSH WITHIN-RUN PRECISION TEST, HOWEVER, THE CUSTOMER DECLINED TO PERFORM THE REQUESTED PRECISION TESTING, THEREFORE, AN INSTRUMENT RELATED PERFORMANCE ISSUE CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT. A VITROS NBNP2 REAGENT LOT 2131 DID NOT LIKELY CONTRIBUTE TO THE EVENT AS ACCEPTABLE PERFORMANCE WAS OBTAINED AFTER CALIBRATING WITH AN ALTERNATE SET OF VITROS NBNP2 LOT 2131 CALIBRATORS. CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD POINT TO A POTENTIAL SYSTEMIC PERFORMANCE ISSUE WITH VITROS NBNP2 LOT 2131.

Description of Event or Problem

A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A LOWER THAN EXPECTED VITROS NT-PROBNP II (NBNP2) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE TESTED AS A LOT TO LOT CORRELATION WHEN PUTTING VITROS NBNP2 REAGENT LOT 2131 INTO USE ON A VITROS 5600 INTEGRATED SYSTEM. PATIENT SAMPLE 5 VITROS NBNP2 RESULT 1700 PG/ML VERSUS THE EXPECTED RESULT OF 2880 PG/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE LOWER THAN EXPECTED VITROS NBNP2 RESULT WAS OBTAINED WHEN PROCESSING A PATIENT SAMPLE CORRELATION IN ORDER TO DETERMINE THE ACCURACY OF VITROS NBNP2 REAGENT LOT 2131 AND WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF PATIENT HARM REPORTED AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT 613009.