VITROS IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK

Description of Event or Problem

A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT THAT LOWER-THAN-EXPECTED QUALITY CONTROL RESULTS WERE OBTAINED FROM A NON-VITROS MAS QUALITY CONTROL (QC) FLUID WHEN USING VITROS IMMUNODIAGNOSTICS PRODUCTS PSA (PSA) REAGENT LOTS 4650 AND 4660 IN COMBINATION WITH A VITROS 5600 INTEGRATED SYSTEM. VITROS PSA LOT 4650 MAS L3 LOT OIM2712 RESULTS OF 14.223, 15.620, 15.488 NG/ML VERSUS THE EXPECTED RESULT OF 21.0 NG/ML VITROS PSA LOT 4660 MAS L3 LOT OIM2712 RESULT OF 0.239 NG/ML VERSUS THE EXPECTED RESULT OF 21.0 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 PSA RESULTS WERE OBTAINED FROM NON-PATIENT QC FLUIDS. THERE WAS 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 DETERMINED THAT LOWER-THAN-EXPECTED QUALITY CONTROL RESULTS WERE OBTAINED FROM A NON-VITROS MAS QUALITY CONTROL (QC) FLUID WHEN USING VITROS IMMUNODIAGNOSTICS PRODUCTS PSA (PSA) REAGENT LOTS 4650 AND 4660 IN COMBINATION WITH A VITROS 5600 INTEGRATED SYSTEM. THE ASSIGNABLE CAUSE OF THE EVENT IS UNKNOWN. HISTORICAL QC FOR VITROS PSA LOTS 4650 AND 4660 WAS ACCURATE AND PRECISE, INDICATING AN ISSUE WITH VITROS PSA REAGENT LOTS 4650 AND 4660 DID NOT LIKELY CONTRIBUTOR TO THE EVENT. ADDITIONALLY, CONTINUAL TRACKING AND TRENDING DOES NOT INDICATE A SYSTEMIC ISSUE WITH VITROS PSA LOTS 4650 AND 4660. AN ISSUE ISOLATED TO THE CALIBRATIONS IN USE DID NOT LIKELY CONTRIBUTE TO THE EVENT, AS ACCEPTABLE RESULTS WERE OBTAINED WITHIN THE SAME CALIBRATION EVENTS THAT PRODUCED THE UNACCEPTABLE RESULTS. AN ISSUE ISOLATED TO THE VITROS PSA LOT 4650 AND 4660 REAGENT PACKS IN USE IS NOT A LIKELY CONTRIBUTOR TO THE EVENT, AS ACCEPTABLE RESULTS WERE OBTAINED WITHIN THE SAME REAGENT PACKS PRIOR TO THE EVENTS. ACCEPTABLE VITROS TSH DIAGNOSTIC PRECISION TESTING INDICATED THAT THE VITROS 5600 SYSTEM WAS PERFORMING AS EXPECTED AND DID NOT LIKELY CONTRIBUTE TO THE EVENT.