BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK

    MDR report key: 7036924 · Received November 16, 2017

    Report

    Report Number
    3007111389-2017-00184
    Event Type
    Malfunction
    Date Received
    November 16, 2017
    Date of Event
    October 23, 2017
    Report Date
    November 16, 2017
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A DISCORDANT (B)(6) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE USING VITROS AHCV REAGENT IN COMBINATION WITH A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM, WHEN COMPARED TO A (B)(6) RESULT OBTAINED FROM A NON-VITROS FUJIREBIO INNO-LIA SYSTEM. AN ASSIGNABLE CAUSE FOR THE DISCORDANCE CANNOT BE IDENTIFIED. BASED ON THE LIMITED HISTORICAL QUALITY CONTROL RESULTS PROVIDED, A VITROS ANTI-HCV REAGENT LOT 4130 PERFORMANCE ISSUE IS NOT A LIKELY CONTRIBUTOR TO THE EVENT. DIAGNOSTIC WITHIN RUN PRECISION TESTING OF THE VITROS 3600 IMMUNODIAGNOSTIC SYSTEM WAS NOT PERFORMED WHEN REQUESTED, THEREFORE IT CANNOT BE CONFIRMED THAT THE INSTRUMENT WAS OPERATING AS INTENDED AND UNEXPECTED INSTRUMENT PERFORMANCE CANNOT BE COMPLETELY RULED OUT AS CONTRIBUTING TO THE EVENT. THE CUSTOMER WAS NOT 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 SAMPLES, ALTHOUGH THIS COULD NOT BE CONFIRMED. IN ADDITION, FROM THE INFORMATION PROVIDED, IT APPEARS THE CUSTOMER WAS NOT FOLLOWING THE ORTHO IFU RECOMMENDATION FOR INTERPRETATION OF RESULTS AS REPEAT TESTING OF THE BORDERLINE SAMPLE WAS ONLY PERFORMED IN SINGLETON AND NOT DUPLICATE AS INSTRUCTED IN THE IFU. AS A RESULT, IT IS UNCLEAR IF THE SAMPLE SHOULD BE CONSIDERED (B)(6) USING THE VITROS AHCV REAGENT. THE CUSTOMER DID PERFORM SUPPLEMENTAL TESTING TO CONFIRM THE SAMPLE WAS (B)(6). HOWEVER, SINCE THE CUSTOMER DID NOT RETEST THE SAMPLE IN DUPLICATE THERE IS INSUFFICIENT EVIDENCE TO SUGGEST THE VITROS AHCV REAGENT DID NOT FUNCTION AS INTENDED.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED A DISCORDANT (B)(6) RESULT OBTAINED FROM A SINGLE PATIENT SAMPLE USING VITROS AHCV REAGENT IN COMBINATION WITH A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM, WHEN COMPARED TO A (B)(6) RESULT OBTAINED FROM A NON-VITROS FUJIREBIO INNO-LIA SYSTEM. PATIENT 1 VITROS (B)(6) RESULT (B)(6) VERSUS EXPECTED (B)(6) RESULT. DISCORDANT RESULTS COULD LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE DISCORDANT (B)(6) RESULT WAS NOT REPORTED FROM THE LABORATORY AND ORTHO WAS NOT MADE AWARE OF ANY ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    815558 VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK IN VITRO DIAGNOSTIC MZO ORTHO-CLINICAL DIAGNOSTICS 4130

    Patients

    Seq Age Sex Outcome Treatment
    1