VITROS IMMUNODIAGNOSTIC PRODUCTS BRAHMS PCT REAGENT PACK

Description of Event or Problem

A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS B¿R¿A¿H¿M¿S PROCALCITONIN (PCT) QC FLUID RESULTS WERE OBTAINED FROM VITROS B¿R¿A¿H¿M¿S PCT LOT 0360 LEVEL 2 QUALITY CONTROL (QC) FLUID, USING VITROS IMMUNODIAGNOSTIC PRODUCTS B¿R¿A¿H¿M¿S PCT REAGENT ON A VITROS 5600 INTEGRATED SYSTEM VITROS B¿R¿A¿H¿M¿S PCT LEVEL 2 RESULTS OF 0.03 AND 0.03 NG/ML VERSUS THE EXPECTED RESULT OF 1.91 NG/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 B¿R¿A¿H¿M¿S PCT RESULTS WERE FROM NON-PATIENT FLUID. THE CUSTOMER DID NOT GIVE ANY INDICATION THAT PATIENT RESULTS HAD BEEN AFFECTED AND THERE IS 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 (B)(4).

Additional Manufacturer Narrative

THE INVESTIGATION HAS DETERMINED THAT LOWER THAN EXPECTED VITROS B¿R¿A¿H¿M¿S PROCALCITONIN (PCT) QC FLUID RESULTS WERE OBTAINED FROM VITROS B¿R¿A¿H¿M¿S PCT LOT 0360 LEVEL 2 QUALITY CONTROL (QC) FLUID, USING VITROS IMMUNODIAGNOSTIC PRODUCTS B¿R¿A¿H¿M¿S PCT REAGENT ON A VITROS 5600 INTEGRATED SYSTEM A DEFINITIVE ASSIGNABLE CAUSE FOR THE LOWER THAN EXPECTED VITROS B¿R¿A¿H¿M¿S PCT RESULTS COULD NOT BE DETERMINED. BASED ON HISTORICAL QUALITY CONTROL RESULTS, A VITROS B¿R¿A¿H¿M¿S PCT REAGENT LOT 0370 PERFORMANCE ISSUE IS NOT A LIKELY CONTRIBUTOR TO THE EVENT. ADDITIONALLY, THE CUSTOMER INDICATED THAT THE VITROS 5600 INTEGRATED SYSTEM WAS HAVING SOME ISSUES AT THE TIME OF THE EVENT WITH WELL WASH TEMPERATURE AND THE COMPRESSOR. HOWEVER, THE CUSTOMER DID NOT PERFORM AN APPROPRIATE WITHIN RUN PRECISION TEST AT THE TIME OF THE EVENT TO DEFINITIVELY RULE OUT AN INSTRUMENT ISSUE AND THEREFORE, UNEXPECTED INSTRUMENT PERFORMANCE CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT. HANDLING AND PROCESSING OF THE VITROS QC SAMPLES COULD BE RULED OUT AS A CONTRIBUTING FACTOR AS IT WAS ESTABLISHED THE CUSTOMER WAS FOLLOWING THE CONTROL STORAGE, PREPARATION AND HANDLING REQUIREMENTS AS DETAILED IN THE VITROS B¿R¿A¿H¿M¿S PCT CONTROLS INSTRUCTIONS FOR USE. CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD INDICATE A POTENTIAL SYSTEMATIC ISSUE WITH VITROS B¿R¿A¿H¿M¿S PCT REAGENT LOT 0370.