VITROS IMMUNODIAGNOSTIC PRODUCTS NT-PROBNP II REAGENT PACK

Description of Event or Problem

A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT REPRODUCIBLE, LOWER THAN EXPECTED VITROS NT-PROBNP II (NBNP2) (LOT 0250) RESULTS WERE OBTAINED WHEN A VITROS NBNP2 HIGH RANGE VERIFIER (RV) FLUID (LOT 0510) WAS PROCESSED ON A VITROS XT7600 INTEGRATED SYSTEM. VITROS NBNP2 LOT 0510 HIGH RV RESULTS OF 11891.6, 11829.5, 11325.7, 11401.4 AND 11416.4 PG/ML VERSUS THE EXPECTED RESULT OF 28500 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 VITROS NBNP2 RESULTS WERE OBTAINED WHEN THE CUSTOMER WAS PROCESSING A NON-PATIENT FLUID. THERE HAS BEEN NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO OF TWO MDRS FOR THIS EVENT. 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 REPRODUCIBLE, LOWER THAN EXPECTED VITROS NT-PROBNP II (NBNP2) (LOT 0250) RESULTS WERE OBTAINED WHEN A VITROS NBNP2 HIGH RANGE VERIFIER (RV) FLUID (LOT 0510) WAS PROCESSED ON A VITROS XT7600 INTEGRATED SYSTEM. A DEFINITIVE CAUSE OF THE EVENT WAS NOT ESTABLISHED. QC RESULTS PRIOR TO AND FOLLOWING THE EVENT INDICATE ACCEPTABLE VITROS NBNP2 LOT 0250 REAGENT PERFORMANCE AND ONGOING TRACKING AND TRENDING OF COMPLAINT DATA DID NOT IDENTIFY ANY SIGNALS TO SUGGEST THERE IS A SYSTEMIC QUALITY ISSUE WITH VITROS NBNP2 LOT 0250. THEREFORE, A VITROS NBNP2 LOT 0250 REAGENT ISSUE DID NOT LIKELY CONTRIBUTE TO THE EVENT. THERE WAS NO EVIDENCE OF AN INSTRUMENT MALFUNCTION AND QC RESULTS PRIOR TO AND FOLLOWING THE EVENT INDICATE ACCEPTABLE PERFORMANCE OF THE VITROS XT7600 INTEGRATED SYSTEM. THEREFORE, AN INSTRUMENT ISSUE DID NOT LIKELY CONTRIBUTE TO THE EVENT. THE EVENT WAS ISOLATED TO RESULTS FROM THE HIGH RV VITROS NBNP2 RV LOT 0510. IT IS POSSIBLE THERE WAS AN ISSUE WITH THE HIGH RV FLUID, SUCH AS A PRE-ANALYTICAL ISSUE OR AN ISSUE WITH AFFECTED VIALS, HOWEVER, THIS COULD NOT BE CONFIRMED. THE RESULTS FROM THE TESTING OF THE HIGH RV FLUID FROM AN ALTERNATE LOT WERE ACCEPTABLE.