BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAMMA CLONE ANTI-D LGM-LGG (MONOCLONAL BLEND)

    MDR report key: 721357 · Received May 26, 2006

    Report

    Report Number
    1034569-2006-00011
    Event Type
    Malfunction
    Date Received
    May 26, 2006
    Date of Event
    January 3, 2006
    Report Date
    May 26, 2006
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AN OB PT WHO WAS PREVIOUSLY TYPED AS O NEG AT THE FACILITY TYPED AS O POS, RH LG WAS ADMIN AS A RESULT OF THE ORIGINAL TEST RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GAMMA CLONE ANTI-D LGM-LGG (MONOCLONAL BLEND) BLOOD GROUPING SERA KSZ IMMUCOR * DMB58-2

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other