VITROS IMMUNODIAGNOSTICS PRODUCTS NT-PROBNP REAGENT PACK

Description of Event or Problem

THE CUSTOMER COMPLAINED OF NONREPRODUCIBLE, HIGHER THAN EXPECTED VITROS NTPROBNP RESULTS FROM ONE BIORAD CONTROL SAMPLE PROCESSED ON A VITROS 5600 INTEGRATED SYSTEM. BIORAD L1= 2740.2 AND 7032.0 PG/ML VS EXPECTED 241.3 PG/ML. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THERE WAS NO ALLEGATION THAT PATIENT SAMPLES WERE AFFECTED; HOWEVER, THE INVESTIGATION CANNOT RULE OUT THE POSSIBILITY THAT PATIENT SAMPLES WERE AFFECTED OR COULD BE AFFECTED IF THE EVENTS WERE TO CONTINUE UNDETECTED. THERE WERE NO ALLEGATIONS OF PATIENT HARM MADE AS A RESULT OF THE EVENTS. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBER (B)(4).

Additional Manufacturer Narrative

THE INVESTIGATION CONFIRMED THAT NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS NT-PROBNP RESULTS WERE OBTAINED FROM ONE BIORAD CONTROL SAMPLE PROCESSED ON A VITROS 5600 INTEGRATED SYSTEM. THE INVESTIGATION DETERMINED THE MOST LIKELY CAUSE TO BE AN UNEXPECTED PERFORMANCE ISSUE ISOLATED TO A SINGLE REAGENT PACK OF VITROS NTBNP REAGENT. THERE WAS NO DATA SUGGESTING AN INSTRUMENT MALFUNCTION CONTRIBUTED TO THE EVENT.