BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAMMACLONE ANTI-D (MONOCLONAL BLEND)

    MDR report key: 792569 · Received November 30, 2006

    Report

    Report Number
    1034569-2006-00178
    Event Type
    Malfunction
    Date Received
    November 30, 2006
    Date of Event
    October 23, 2006
    Report Date
    November 29, 2006
    Manufacturer
    GAMMA BIOLOGICALS, INC.
    Product Code
    KSZ
    PMA / PMN Number
    103629
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER DID NOT SEND SAMPLES FOR INVESTIGATION TESTING. THE PACKAGE INSERT STATES: "CERTAIN RARE RED BLOOD CELLS THAT APPEAR TO BE D-NEGATIVE WITH OTHER ANTI-D REAGENTS WILL REACT UNEXPECTEDLY WITH THIS REAGENT. RED BLOOD CELLS OF THE CRAWFORD PHENOTYPE ARE AGGLUTINATED AT THE IMMEDIATE-SPIN TEST PHASE AND ARE USUALLY NONREACTIVE AT THE WEAK D PHASE." THE EVENT WAS WITHIN THE LIMITATIONS STATED IN THE PACKAGE INSERT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED POSITIVE REACTIONS (4+) AT IMMEDIATE SPIN (IS) WITH GAMMACLONE ANTI-D (MONOCLONAL BLEND) WITH 3 PATIENTS. THE PATIENTS' SERUM ALSO CONTAINED ANTI-D. WEAK D TESTING RESULTED AS POSITIVE (4+). CUSTOMER STATES ONE PATIENT WAS TYPED AS B, RH NEGATIVE AND WAS GIVEN RHIG. THE OTHER 2 PATIENTS, 1 MALE AND 1 FEMALE TYPED AS RH POSITIVE WITH ANTI-D IN THEIR SERA WITH NO HISTORY OF RECEIVING RHIG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GAMMACLONE ANTI-D (MONOCLONAL BLEND) BLOOD GROUPING REAGENT KSZ GAMMA BIOLOGICALS, INC. * DMB63-1

    Patients

    Seq Age Sex Outcome Treatment
    1 *