VITROS IMMUNODIAGNOSTIC PRODUCTS NT PROBNP REAGENT PACK

Description of Event or Problem

A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A HIGHER THAN EXPECTED VITROS NT PRO-BNP II RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE WHEN USING VITROS IMMUNODIAGNOSTICS PRODUCTS NT PRO-BNP II REAGENT LOT 0440 IN COMBINATION WITH A VITROS 5600 INTEGRATED SYSTEM. PATIENT SAMPLE RESULT OF >30000 PG/ML VERSUS THE EXPECTED RESULT OF <300 PG/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE DISCORDANT VITROS RESULT WAS NOT REPORTED FROM THE LABORATORY. ORTHO HAS NOT BEEN MADE AWARE OF ANY ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT 600489.

Additional Manufacturer Narrative

THE INVESTIGATION DETERMINED THAT A HIGHER THAN EXPECTED VITROS NT PRO-BNP II RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE WHEN USING VITROS IMMUNODIAGNOSTICS PRODUCTS NT PRO-BNP II REAGENT LOT 0440 IN COMBINATION WITH A VITROS 5600 INTEGRATED SYSTEM. A DEFINITIVE ASSIGNABLE CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. BASED ON HISTORICAL QUALITY CONTROL RESULTS, A VITROS LOT 0440 PERFORMANCE ISSUE IS NOT A LIKELY CONTRIBUTOR TO THE EVENT. HOWEVER, IT CANNOT BE COMPLETELY RULED OUT AS THE DISCORDANT RESULT WAS GENERATED ON AN EXPIRED REAGENT LOT. AN INSTRUMENT RELATED PERFORMANCE ISSUE DID NOT LIKELY CONTRIBUTE TO THE EVENT AS THE CUSTOMER GAVE NO INDICATION OF ANY INSTRUMENT MALFUNCTION AS ALL OTHER TESTS PREDICTED AS EXPECTED. IT WAS NOT POSSIBLE TO ESTABLISH IF THE CUSTOMER IS FOLLOWING THE SAMPLE COLLECTION DEVICE MANUFACTURER¿S RECOMMENDED CENTRIFUGATION PROTOCOL; THEREFORE, PRE-ANALYTICAL SAMPLE PROCESSING CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR. IT IS POSSIBLE THAT CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, WAS PRESENT IN THE AFFECTED SAMPLE, ALTHOUGH THIS COULD NOT BE CONFIRMED. ADDITIONALLY, THE PRESENCE OF AN UNKNOWN SAMPLE SPECIFIC INTERFERENT CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT. CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD POINT TO A POTENTIAL SYSTEMIC ISSUE WITH VITROS NT PRO-BNP II, LOT 0440.