BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-D (MONOCLONAL BLEND) SERIES4

    MDR report key: 1001592 · Received February 25, 2008

    Report

    Report Number
    1034569-2008-00045
    Event Type
    Malfunction
    Date Received
    February 25, 2008
    Date of Event
    January 28, 2008
    Report Date
    February 14, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    103523 STN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING WAS PERFORMED WITH RETENTION ANTI-D (MONOCLONAL BLEND) SERIES 4, LOTS 504688 AND 504694, AND GAMMA-CLONE ANTI-D (MONOCLONAL BLEND), LOT DMB69-4, USING RED CELLS OF VARIOUS RH PHENOTYPES INCLUDENG WEAK D CELLS; THE EXPECTED REACTIVITY WAS OBSERVED IN ALL TESTING. TESTING WAS PERFORMED WITH CUSTOMER'S RETURNED SAMPLES USING A VARIETY OF MANUFACTURERS' ANTI-D REAGENTS, INCLUDING RETENTION ANTI-D SERIES 4, LOTS 504688 AND 504694, AND ANTI-D (MONOCLONAL BLEND), LOT DMB69-4. ONE SAMPLE EXHIBITED VERY WEAK REACTIVITY AT IAT WITH ALL ANTI-D REAGENTS TESTED. THE OTHER SAMPLE EXHIBITED MODERATE REACTIVITY AT IS WITH ANTI-D (MONOCLONAL BLEND), WEAK REACTIVITY WITH ALL ANTI-D REAGENTS AT 37C, AND WEAK TO MODERATE REACTIVITY AT THE ANTIGLOBULIN PHASE WITH ALL ANTI-D REAGENTS TESTED. THE CUSTOMER DID NOT RETURN PRODUCT FOR INVESTIGATION. IT WAS REPORTED TO THE CUSTOMER THAT DONORS COULD POSSES WEAKER EXPRESSIONS OF THE D ANTIGEN THAT MAY REACT DIFFERENTLY WITH DIFFERENT CLONES. ALSO, TECHNICAL ERRORS CAN NOT BE RULED OUT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT TWO DIFFERENT DONORS WERE TYPED FOR FIRST TIME USING ANTI-D (MONOCLONAL BLEND) SERIES 4 AS D NEGATIVE, WEAK D NEGATIVE. CUSTOMER WAS NOTIFIED THAT BOTH DONORS, FROM TWO DIFFERENT RECEIVING FACILITIES, TYPED D POSITIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTI-D (MONOCLONAL BLEND) SERIES4 BLOOD GROUPING REAGENT KSZ IMMUCOR, INC. 504688

    Patients

    Seq Age Sex Outcome Treatment
    1