BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAMMACLONE ANTI-D (MONOCLONAL BLEND)

    MDR report key: 765116 · Received August 4, 2006

    Report

    Report Number
    1034569-2006-00080
    Event Type
    Malfunction
    Date Received
    August 4, 2006
    Date of Event
    July 21, 2006
    Report Date
    August 4, 2006
    Manufacturer
    GAMMA BIOLOGICALS, INC.
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING WAS PERFORMED USING THE TUBE METHOD. PATIENT'S SAMPLE WAS SENT TO THE ARC REFERENCE LAB FOR INDENTIFICATION, ACCORDING TO THE CUSTOMER. THE FOLLOWING WERE INDENTIFIED; ANTI-C, -V, -JSA AND A WARM AUTOANTIBODY. THE SAMPLE WAS NOT RETURNED TO IMMUCOR FOR EVALUATION. THE PACKAGE INSERT INDICATES: "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, DUE TO THE NATURE OF THE SAMPLE, WAS WITHIN THE LIMITATIONS STATED IN THE PACKAGE INSERT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED POSITIVE REACTIONS (1+S TO 2+) AT THE IMMEDIATE SPIN (IS) PHASE WITH GAMMACLONE ANTI-D, (MONOCLONAL BLEND) WHEN TESTING A PREVIOUSLY TYPED RH NEGATIVE PATIENT. PATIENT WAS EMERGENTLY TRANSFUSED WITH 4 UNITS OF O POSITIVE RED BLOOD CELLS AFTER BEING TYPED AS O POSITIVE WITH THE GAMMACLONE ANTI-D. A TRANSFUSION REACTION WAS NOT CALLED BY THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GAMMACLONE ANTI-D (MONOCLONAL BLEND) BLOOD GROUPING REAGENT KSZ GAMMA BIOLOGICALS, INC. * DMB61-5

    Patients

    Seq Age Sex Outcome Treatment
    1 *