VITROS IMMUNODIAGNOSTIC PRODUCTS NT-PROBNP II REAGENT PACK

Additional Manufacturer Narrative

THE INVESTIGATION DETERMINED THAT A LOWER THAN EXPECTED NT-PROBNP II (NBNP2) RESULT WAS OBTAINED WHEN A LEVEL 3 BIORAD QC FLUID WAS PROCESSED USING VITROS NBNP2 LOT 0260 ON A VITROS XT 7600 INTEGRATED SYSTEM. A DEFINITIVE ASSIGNABLE CAUSE OF THE EVENT WAS NOT ESTABLISHED. HISTORICAL QC RESULTS LEADING UP TO THE EVENT INDICATE ACCEPTABLE PERFORMANCE OF VITROS NBNP2 LOT 0260. ADDITIONALLY, ONGOING TRACKING AND TRENDING OF COMPLAINT DATA DID NOT IDENTIFY ANY SIGNALS TO SUGGEST THERE IS A SYSTEMIC QUALITY ISSUE WITH VITROS NBNP2 LOT 0260. AN INSTRUMENT ISSUE CANNOT BE RULED OUT AS A CONTRIBUTOR TO THE EVENT, AS NO DIAGNOSTIC PRECISION TESTING WAS CONDUCTED AROUND THE TIME THE LOWER THAN EXPECTED RESULT WAS OBTAINED TO VERIFY THE PERFORMANCE OF THE VITROS XT 7600 INTEGRATED SYSTEM. IT IS POSSIBLE IMPROPER HANDLING OF THE BIORAD QCS CONTRIBUTED TO THE EVENT, HOWEVER, THIS COULD NOT BE CONFIRMED, AS IT WAS NOT POSSIBLE TO DETERMINE WHETHER THE CUSTOMER HANDLED THE BIORAD LEVEL 3 QC ACCORDING TO THE INSTRUCTIONS PRIOR TO PROCESSING THE FLUID ON THE INSTRUMENT.

Description of Event or Problem

A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A LOWER THAN EXPECTED NT-PROBNP II (NBNP2) RESULT WAS OBTAINED WHEN A LEVEL 3 BIORAD QC FLUID WAS PROCESSED USING VITROS NBNP2 LOT 0260 ON A VITROS XT 7600 INTEGRATED SYSTEM. BIORAD 67703 RESULT OF 42.45 PG/ML VERSUS THE BASELINE MEAN RESULT OF 2500 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 RESULT WAS 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 CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBERS (B)(4) AND REPORTABILITY ASSESSMENT 607157.