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 2 BIORAD QC FLUID WAS PROCESSED USING VITROS NBNP2 LOT 0610 ON A VITROS XT 7600 INTEGRATED SYSTEM. A DEFINITIVE ASSIGNABLE CAUSE OF THE EVENT WAS NOT ESTABLISHED. QC RESULTS PRIOR TO AND FOLLOWING THE EVENT INDICATE ACCEPTABLE VITROS NBNP2 LOT 0610 PERFORMANCE AND ONGOING TRACKING AND TRENDING OF COMPLAINT DATA DID NOT IDENTIFY ANY SIGNALS TO SUGGEST THERE IS A SYSTEMIC QUALITY ISSUE WITH VITROS NBNP2 LOT 0610. THE LOWER THAN EXPECTED VITROS NBNP2 RESULTS FROM BIORAD QC TESTING WERE ISOLATED TO THE TESTING OF THE BIORAD LEVEL 2 QC ON 15 DECEMBER 2025. IT IS POSSIBLE AN INSTRUMENT ISSUE CONTRIBUTED TO THE LOWER THAN EXPECTED RESULTS, HOWEVER, THIS COULD NOT BE CONFIRMED. SERVICE ACTIONS TO THE INSTRUMENT BY AN ORTHO FIELD ENGINEER (FE) INCLUDED REPLACEMENT OF WORN COMPONENTS, CLEANING OF THE MICROWELL INCUBATOR AND POST-REQUISITE ADJUSTMENTS. NO FURTHER ACTIONS WERE TAKEN BY THE ORTHO FE TO OPTIMIZE THE INSTRUMENT. QC RESULTS FOLLOWING ORTHO FE SERVICE ACTIONS WERE DEEMED ACCEPTABLE AND THERE HAVE BEEN NO FURTHER REPORTED ISSUES WITH VITROS MICROWELL RESULTS ON THE VITROS XT 7600 INTEGRATED SYSTEM. WITHIN-RUN DIAGNOSTIC PRECISION TESTING PRIOR TO AND FOLLOWING ORTHO FE SERVICE ACTIONS INDICATE ACCEPTABLE PERFORMANCE OF THE VITROS XT 7600 INTEGRATED SYSTEM. HOWEVER, UNACCEPTABLE QC RESULTS ON THE DATE OF THE EVENT WERE ALSO OBSERVED FROM VITROS TROPI ES, VITROS PSA, VITROS BHCG2 AND VITROS PCT TESTING ON THE VITROS XT 7600 INTEGRATED SYSTEM. THEREFORE, AN INSTRUMENT ISSUE ON THE DATE OF THE EVENT CANNOT BE RULED OUT AS A CONTRIBUTOR TO THE EVENT. AN ISSUE RELATED TO IMPROPER HANDLING OF QC MATERIAL IS AN UNLIKELY CONTRIBUTOR TO THE EVENT, AS UNACCEPTABLE VITROS NBNP2, VITROS TROPI ES, VITROS PSA, VITROS BHCG2 AND VITROS PCT RESULTS WERE OBTAINED FROM THREE DIFFERENT SETS OF QCS. THEREFORE, IT IS UNLIKELY IMPROPER HANDLING OF THE THREE DIFFERENT SETS OF QCS CONTRIBUTED TO THE EVENT.

Description of Event or Problem

A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED NT-PROBNP II (NBNP2) RESULTS WERE OBTAINED WHEN A LEVEL 2 BIORAD QC FLUID WAS PROCESSED USING VITROS NBNP2 LOT 0610 ON A VITROS XT7600 INTEGRATED SYSTEM. BIORAD 67712 (LEVEL 2) RESULTS OF 114.89, 116.89 AND 135.47 PG/ML VERSUS THE CUSTOMERS ESTABLISHED BASELINE MEAN VALUE OF 195 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 A NON-PATIENT FLUID. HOWEVER, THE INVESTIGATION CANNOT RULE OUT THAT PATIENT SAMPLE RESULTS WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. 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) AND REPORTABILITY ASSESSMENT 613073.