VITROS IMMUNODIAGNOSTICS PRODUCTS NT-PROBNP REAGENT PACK

Description of Event or Problem

THE CUSTOMER COMPLAINED THAT LOWER THAN EXPECTED VITROS NT-PROBNP QUALITY CONTROL RESULTS WERE OBTAINED ON A VITROS 5600 INTEGRATED SYSTEM. (B)(6) 2015, VITROS NT-PROBNP RESULTS USING BR 23572: 19.448 PG/ML VS EXPECTED 654.28 PG/ML. (B)(6) 2015, VITROS NT-PROBNP RESULTS USING BR 23572: 5 PG/ML VS EXPECTED 654.28 PG/ML. VITROS NT-PROBNP RESULTS USING CLQ L2: 20.06 PG/ML VS EXPECTED 565 PG/ML. VITROS NT-PROBNP RESULTS USING CLQ L3: 5 PG/ML VS EXPECTED 5032 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 ONE 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 LOWER THAN EXPECTED VITROS NT-PROBNP QUALITY CONTROL RESULTS WERE OBTAINED ON A VITROS 5600 INTEGRATED SYSTEM ALTHOUGH PRE-ANALYTICAL SAMPLE HANDLING IS SUSPECTED AS A CONTRIBUTING FACTOR TO THE LOWER THAN EXPECTED RESULTS ON (B)(6) 2015, A DEFINITIVE ASSIGNABLE CAUSE IS UNKNOWN. ACCEPTABLE RESULTS WERE OBTAINED USING FRESH ALIQUOTS OF BIORAD CONTROLS TESTED USING THE SAME NT-PROBNP REAGENT PACK. THE ASSIGNABLE CAUSE FOR THE (B)(6) 2015 EVENT IS MOST LIKELY REAGENT RELATED, AS THE LOWER THAN EXPECTED VITROS NT-PROBNP RESULTS WERE ISOLATED TO A SINGLE REAGENT PACK. ACCEPTABLE RESULTS WERE OBSERVED AFTER REPLACEMENT OF THE AFFECTED PACK, USING THE SAME VITROS NT-PROBNP REAGENT LOT. THE INVESTIGATION DETERMINED THAT THERE WAS NO INDICATION OF A TRANSIENT VITROS 5600 SYSTEM ISSUE.