BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK

    MDR report key: 6770035 · Received August 7, 2017

    Report

    Report Number
    3007111389-2017-00118
    Event Type
    Malfunction
    Date Received
    August 7, 2017
    Date of Event
    May 26, 2017
    Report Date
    August 7, 2017
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LOM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT (B)(6) VITROS ANTI HBC IGM RESULTS WERE OBTAINED FROM A SINGLE AAB PROFICIENCY SAMPLE PROCESSED USING VITROS ANTI HBC IGM REAGENT LOT 7640 ON A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM, WHEN COMPARED TO THE EXPECTED (B)(6) RESULT ASSIGNED BY THE PROFICIENCY PROVIDER. THE DEFINITIVE ASSIGNABLE CAUSE OF THE EVENT COULD NOT BE DETERMINED. BASED ON HISTORICAL QUALITY CONTROL RESULTS, THERE IS NO INDICATION A REAGENT RELATED ISSUE CONTRIBUTED TO THE EVENT. THERE IS ALSO NO INDICATION OF AN INSTRUMENT MALFUNCTION AND UNEXPECTED INSTRUMENT PERFORMANCE IS NOT A LIKELY CONTRIBUTOR TO THE EVENT. THE PRESENCE OF AN UNKNOWN SAMPLE INTERFERENT CANNOT BE COMPLETELY RULED OUT AS THE CAUSE OF THE (B)(6) RESULTS AS NO RESULTS USING NABT OR HBT TUBES WERE PROVIDED BY THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED (B)(6) VITROS ANTI HBC IGM RESULTS FOR A SINGLE ASSOCIATION OF AMERICAN BIOANALYSTS (AAB) PROFICIENCY SAMPLE WHEN COMPARED TO THE EXPECTED (B)(6) RESULT, PROCESSED USING VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI HBC IGM REAGENT LOT 7640 ON A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. (B)(6). THE LOWER THAN EXPECTED VITROS ANTI HBC IGM AAB PROFICIENCY FLUID RESULT WAS OBTAINED FROM A NON PATIENT FLUID AND WAS REPORTED TO THE PROFICIENCY PROVIDER. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF PATIENT SAMPLES WERE AFFECTED. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550204 VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK IN-VITRO DIAGNOSTIC LOM ORTHO-CLINICAL DIAGNOSTICS 7640

    Patients

    Seq Age Sex Outcome Treatment
    1