VITROS IMMUNODIAGNOSTIC PRODUCTS NT-PROBNP II REAGENT PACK

Additional Manufacturer Narrative

THE INVESTIGATION DETERMINED THAT LOWER THAN EXPECTED NBNP2 RESULTS WERE OBTAINED WHEN A LEVEL 3 BIORAD QC FLUID WAS PROCESSED USING VITROS NBNP2 LOT 2200 AND LOT 2230 ON A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. A DEFINITIVE CAUSE OF THE EVENT WAS NOT ESTABLISHED. LOW BIAS WAS OBSERVED FROM BOTH LEVELS OF BIORAD QCS (LEVEL 2 AND LEVEL 3) PROCESSED BY THE CUSTOMER. THE CUSTOMER SUSPECTED A POTENTIAL ISSUE WITH THE BIORAD QCS, HOWEVER, THIS COULD NOT BE CONFIRMED. IN ADDITION, THE CUSTOMER DID NOT PROCESS A QC CLOSER TO THE LOWER END OF THE VITROS NBNP2 AMR. THEREFORE, THE PERFORMANCE OF THE VITROS NBNP2 REAGENT AT THE LOW END OF THE AMR COULD NOT BE VERIFIED. QC RESULTS SINCE THE CUSTOMER PUT INTO USE VITROS NBNP2 LOT 2245 SHOWED IMPROVED ACCURACY BUT UNACCEPTABLE PRECISION. THE CUSTOMER WAS SENT VITROS NBNP2 CONTROLS, HOWEVER, AT THE TIME OF WRITING THIS INVESTIGATION, NO RESULTS FROM VITROS NBNP2 CONTROL TESTING HAVE BEEN PROVIDED. NO PRECISION TESTING WAS PERFORMED ON THE INSTRUMENT, SO IT WAS NOT POSSIBLE TO VERIFY THE PERFORMANCE OF THE INSTRUMENT AT THE TIME OF THE EVENT. THEREFORE, AN INSTRUMENT ISSUE CANNOT BE COMPLETELY RULED OUT AS CONTRIBUTING TO THE EVENT, ALTHOUGH, THERE IS NO EVIDENCE OR ANY SUGGESTION FROM THE CUSTOMER THAT THE INSTRUMENT WAS NOT PERFORMING AS INTENDED. NO INFORMATION WAS PROVIDED IN RELATION TO THE HANDLING OF THE BIORAD QCS; THEREFORE, IMPROPER QC FLUID HANDLING CANNOT BE RULED OUT AS A CONTRIBUTOR TO THE EVENT. ONGOING TRACKING AND TRENDING OF COMPLAINT DATA DID NOT IDENTIFY ANY SIGNALS TO SUGGEST THERE IS A SYSTEMIC QUALITY ISSUE WITH VITROS NBNP2 LOT 2200 OR LOT 2230.

Description of Event or Problem

A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED NBNP2 RESULTS WERE OBTAINED WHEN A LEVEL 3 BIORAD QC FLUID WAS PROCESSED USING VITROS NBNP2 LOT 2200 AND LOT 2230 ON A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. BIORAD LOT 1003123 (LEVEL 3), VITROS NBNP2 LOT 2200 RESULTS OF 1217.34, 1163.83, 1173.65, 1212.79, 1211.16, 1167.65, 1155.88 AND 1160.77 PG/ML VERSUS THE BASELINE MEAN RESULT OF 1636.0 PG/ML BIORAD LOT 1003123 (LEVEL 3), VITROS NBNP2 LOT 2230 RESULTS OF 1189.34, 1155.1, 1162.1, 1129.16 AND 1091.87 PG/ML VERSUS THE BASELINE MEAN RESULT OF 1636.0 PG/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE LOWER-THAN-EXPECTED VITROS NBNP2 RESULTS WERE OBTAINED WHEN THE CUSTOMER WAS PROCESSING NON-PATIENT FLUIDS. THERE HAS BEEN NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO OF THREE MDRS FOR THIS EVENT. THREE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS THREE DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBERS (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).