BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTICS PRODUCTS ANTI-HCV REAGENT PACK

    MDR report key: 6995718 · Received November 2, 2017

    Report

    Report Number
    3007111389-2017-00171
    Event Type
    Malfunction
    Date Received
    November 2, 2017
    Date of Event
    October 3, 2017
    Report Date
    November 2, 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

    A DEFINITIVE ASSIGNABLE CAUSE COULD NOT BE DETERMINED. THE MOST LIKELY ASSIGNABLE CAUSE OF THE EVENT WAS A SAMPLE RELATED ISSUE. THE DISCORDANT (B)(6) RESULT WAS REPRODUCIBLE ON FOUR VITROS SYSTEMS AND A NON-VITROS DIOSCORIN LIAISON XL (CHEMILUMINESCENCE TEST). SINCE THE RESULTS WERE REPRODUCIBLE ON FOUR VITROS SYSTEMS AN UNEXPECTED INSTRUMENT PERFORMANCE IS NOT A LIKELY CONTRIBUTOR TO THE EVENT. BASED ON HISTORICAL QUALITY CONTROL RESULTS, A VITROS (B)(6) REAGENT LOT 4130 PERFORMANCE ISSUE IS NOT A LIKELY CONTRIBUTOR TO THE EVENT. IN ADDITION, 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.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED A DISCORDANT (B)(6) VITROS (B)(6) RESULT FROM A SINGLE PATIENT SAMPLE ON A VITROS 5600 INTEGRATED SYSTEM AND A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM WHEN COMPARED TO (B)(6) REACTIVE RESULTS OBTAINED FROM THE SAME PATIENT SAMPLE ON A NON-VITROS FUJIREBIO INNO-LIA SYSTEM. VITROS (B)(6) RESULTS 0.84, 0.81, 0.62, 0.76, AND 0.87 S/C ((B)(6)) VERSUS FUJIREBIO-INNO-LIA REACTIVE RESULT BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED COULD LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE DISCORDANT (B)(6) RESULT WAS NOT REPORTED FROM THE LABORATORY. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THE EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBER (B)(4). THIS REPORT IS NUMBER TWO OF TWO MDR'S FOR THIS EVENT. TWO 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWO DEVICES WERE INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775032 VITROS IMMUNODIAGNOSTICS PRODUCTS ANTI-HCV REAGENT PACK IN-VITRO DIAGNOSTIC MZO ORTHO-CLINICAL DIAGNOSTICS 4120

    Patients

    Seq Age Sex Outcome Treatment
    1