VITROS IMMUNODIAGNOSTIC PRODUCTS NT-PROBNP II REAGENT PACK

Additional Manufacturer Narrative

THE INVESTIGATION DETERMINED THAT A NON-REPRODUCIBLE, LOWER THAN EXPECTED NT-PROBNP RESULT WAS OBTAINED WHEN A SINGLE PATIENT SAMPLE WAS PROCESSED USING VITROS NBNP2 LOT: 2230 ON A VITROS 5600 INTEGRATED SYSTEM. THE MOST LIKELY CAUSE OF THE EVENT WAS AN ISSUE ISOLATED TO PACK ID 0991 OF VITROS NBNP2 LOT: 2230. MULTIPLE PATIENT SAMPLE RESULTS WERE <20 PG/ML FROM TESTING ON PACK ID 0991. REPEAT RESULTS FROM ALTERNATE PACKS FROM VITROS NBNP2 LOT: 2230 TESTING RETURNED EXPECTED RESULTS. THE INVESTIGATION WAS UNABLE TO DETERMINE WHAT THE SPECIFIC ISSUE WAS WITH NBNP2 PACK ID 0991. THE ORTHO TSC REVIEWED THE VITROS NBNP2 LOT: 2230 CALIBRATION DATA AND VITROS 5600 INSTRUMENT DATA; NO MALFUNCTION WAS IDENTIFIED. ONGOING TRACK AND TRENDING HAVE NOT IDENTIFIED A SYSTEMIC ISSUE WITH VITROS NBNP2 LOT: 2230.

Description of Event or Problem

A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A NON-REPRODUCIBLE, LOWER THAN EXPECTED NT-PROBNP RESULT OBTAINED WHEN A SINGLE PATIENT SAMPLE WAS PROCESSED USING VITROS NBNP2 LOT: 2230 ON A VITROS 5600 INTEGRATED SYSTEM. PATIENT 1 RESULT OF <20 PG/ML VERSUS THE REPEAT RESULT OF 3294 PG/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE NON-REPRODUCIBLE, LOWER THAN EXPECTED VITROS NBNP2 RESULT WAS NOT REPORTED FROM THE LABORATORY. THERE HAS BEEN NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER: (B)(4).