BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-HUMAN GLOBULIN (RABBIT/MURINE MONOCLONAL)

    MDR report key: 1983143 · Received January 17, 2011

    Report

    Report Number
    9610824-2011-00005
    Event Type
    Malfunction
    Date Received
    January 17, 2011
    Date of Event
    October 15, 2010
    Report Date
    January 18, 2011
    Manufacturer
    BIO-RAD MED DIAGNOSTICS GMBH
    Product Code
    GMS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT CAP SURVEY (B)(4) FAILED TO REACT (B)(6) WITH ANTI-HUMAN GLOBULIN ANTI-IGG, -C3D, POLYSPECIFIC (B)(4), LOT 7836090-02. THE CUSTOMER HAS SENT US THE SURVEY SAMPLE AND THE COMPLAINED REAGENT. BOTH WERE TESTED IN QUALITY CONTROL LABORATORY. THE SURVEY SAMPLE REACTED CORRECTLY (B)(6) WITH THE AFFECTED LOT OF ANTI-HUMAN GLOBULIN ANTI-IGG, -C3D, POLYSPECIFIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTI-HUMAN GLOBULIN (RABBIT/MURINE MONOCLONAL) ANTI-HUMAN GLOBULIN, ANTI-IGG, -C3D, POLY. GMS BIO-RAD MED DIAGNOSTICS GMBH 7836090-02

    Patients

    Seq Age Sex Outcome Treatment
    1