VITROS IMMUNODIAGNOSTICS PRODUCTS NT-PROBNP REAGENT PACK

Description of Event or Problem

THE CUSTOMER COMPLAINED OF NONREPRODUCIBLE, LOWER THAN EXPECTED VITROS NTPROBNP RESULTS FROM TWO BIORAD CONTROL SAMPLES PROCESSED ON A VITROS 5600 INTEGRATED SYSTEM. SAMPLE 1= 16.5771PG/ML VS EXPECTED 694.0 PG/ML. SAMPLE 2= 17.9442 PG/ML VS EXPECTED 694.0 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 IS NUMBER TWO OF TWO MDR¿S 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. (B)(4).

Additional Manufacturer Narrative

THE INVESTIGATION CONFIRMED THAT NON-REPRODUCIBLE, LOWER THAN EXPECTED VITROS NT-PROBNP RESULTS WERE OBTAINED FROM TWO BIORAD CONTROL SAMPLES PROCESSED ON A VITROS 5600 INTEGRATED SYSTEM. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. NO PRECISION PERFORMANCE TESTING WAS PERFORMED, THEREFORE THE POSSIBILITY THAT AN UNEXPECTED VITROS NTPROBNP REAGENT OR VITROS 5600 SYSTEM PERFORMANCE HAD CONTRIBUTED TO THE RESULTS COULD NOT BE RULED OUT.