BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAMMA ANTI-D BLOOD GROUPING REAGENT

    MDR report key: 809633 · Received June 9, 2006

    Report

    Report Number
    1034569-2006-00025
    Event Type
    Malfunction
    Date Received
    June 9, 2006
    Date of Event
    November 12, 2003
    Manufacturer
    GAMMA BIOLOGICALS INC
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT SPECIMEN AND RETURN PRODUCT WERE NOT RECEIVED FROM CUSTOMER; CUSTOMER WAS CONTACTED AND COULD NOT LOCATE PAPERWORK WITH TRACKING/SHIPPING INFORMATION FOR FOLLOW UP. THE CUSTOMER STATES THAT SHE DOES NOT BELIEVE THAT THERE IS A PROBLEM WITH THE ANTI-D. SHE BELIEVES THE ORIGINAL D-POSITIVE RESULT WAS A TECHNICAL ERROR ON THE PART OF THE TESTING TECHNOLOGIST WHO ORIGINALLY TESTED THE PATIENT AS D-POSITIVE DUE TO CIRCUMSTANCES INVOLVING THE TECHNOLOGIST. RETAINED ANTI-D AND ANTI-D (MONOCLONAL BLEND) PRODUCTS WERE TESTED WITH VARIOUS D-NEGATIVE AND D-POSITIVE RED BLOOD CELLS, INCLUDING WEAK D CELLS. ALL TESTS RESULTS WERE AS EXPECTED AND NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    CUSTOMER STATES A PATIENT WHO PREVIOUSLY TESTED AS D-POSITIVE WITH ANTI-D ONE YEAR AGO IS NOW TESTING D-NEGATIVE WITH ANTI-D (MONOCLONAL BLEND), INCLUDING WEAK D NEGATIVE. BASED ON THE ORIGINAL D-POSITIVE RESULTS, THE PATIENT WAS TRANSFUSED WITH 5 UNITS OF D-POSITIVE RED BLOOD CELLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GAMMA ANTI-D BLOOD GROUPING REAGENT * KSZ GAMMA BIOLOGICALS INC * D239-3

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR