BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAMMACLONE ANTI-D MONOCLONAL BLEND

    MDR report key: 746555 · Received July 26, 2006

    Report

    Report Number
    1034569-2006-00068
    Event Type
    Malfunction
    Date Received
    July 26, 2006
    Date of Event
    June 26, 2006
    Report Date
    July 26, 2006
    Manufacturer
    GAMMA BIOLOGICALS, INC.
    Product Code
    KSZ
    PMA / PMN Number
    103629
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER SAMPLES WERE NOT RETURNED FOR INVESTIGATION TESTING. RETENTION GAMMA-CLONE ANTI-D (MONOCLONAL BLEND), LOT DMB62-1 WAS TESTING WITH IN-HOUSE DONORS OF VARIOUS RH PHENOTYPES, INCLUDING WEAK D CELLS. EXPECTED REACTIVITY WAS OBSERVED. RETENTION PRODUCT PERFORMED AS EXPECTED. ALTHOUGH NO MEDICAL ACTION WAS TAKEN BASED ON THE RESULTS, THE POTENTIAL TRANSFUSION OF INCOMPATBLE BLOOD EXITS.

    Description of Event or Problem · 1

    CUSTOMER STATES THAT THEY ARE GETTING UNEXPECTED RH POSITIVE REACTIONS (1+-2+) AT IMMEDIATE SPIN WITH GAMMACLONE ANTI-D (MONOCLONAL BLEND), LOT DMB62-1 ON PATIENT SAMPLES PREVIOUSLY TYPED AS RH NEGATIVE. THEY ARE ALSO GETTING INCONSISTENT REACTIONS WHEN TYPING NEW PATIENTS: RESULTS OF 1ST TYPING IS RH NEGATIVE AT IMMEDIATE SPIN (IS) AND RESULTS OF 2ND TYPING BY 2ND TECHNOLOGIST IS RH POSITIVE (1+) AT IS. NO MEDICAL ACTION WAS TAKEN AS A RESULT OF THE UNEXPECTED NEGATIVE REACTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GAMMACLONE ANTI-D MONOCLONAL BLEND BLOOD GROUPING REAGENT KSZ GAMMA BIOLOGICALS, INC. * DMB62-1

    Patients

    Seq Age Sex Outcome Treatment
    1 *