BEUDAMED
    FDA Adverse Event Summary report: N

    ANTI-D(MONOCLONAL BLEND) SERIES 5

    MDR report key: 1019245 · Received March 27, 2008

    Report

    Report Number
    1034569-2008-00090
    Date Received
    March 27, 2008
    Date of Event
    March 2, 2008
    Report Date
    March 27, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    103523 STN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES OF VARIOUS RH PHENOTYPES, INCLUDING WEAK D CELLS, WERE TESTED WITH RETENTION ANTI-D SERIES 4, LOT 504696 AND ANTI-D SERIES 5, LOT 505548 ON AN IN-HOUSE ECHO INSTRUMENT. THE EXPECTED REACTIVITY WAS OBSERVED IN ALL TESTING. THE CUSTOMER DID NOT RETURN SAMPLE FOR INVESTIGATION TESTING. IT IS NOT POSSIBLE TO RULE OUT THE SAMPLE AS A CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    CUSTOMER STATES THEY ARE GETTING DISCREPANT RESULTS WITH ANTI-D (MONOCLONAL BLEND), SERIES 4, LOT 504696 AND ANTI-D (MONOCLONAL BLEND), SERIES 5, LOT 505548, WHEN RUNNING REFLEX GROUP/SCEEN ON PATIENT SAMPLE ON THE ECHO. THE SERIES 4 REAGENT WAS RESULTING 3+; SERIES 5 WAS RESULTING NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTI-D(MONOCLONAL BLEND) SERIES 5 BLOOD GROUPING REAGENT KSZ IMMUCOR, INC. 505548

    Patients

    Seq Age Sex Outcome Treatment
    1