BEUDAMED
    FDA Adverse Event Other Summary report: N

    SCREENING CELLS TRIO

    MDR report key: 391663 · Received May 1, 2002

    Report

    Report Number
    1623424-2002-00002
    Event Type
    Other
    Date Received
    May 1, 2002
    Date of Event
    March 9, 2002
    Report Date
    April 30, 2002
    Manufacturer
    GAMMA BIOLOGICALS, INC.
    Product Code
    KSZ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2002, THE PT EXPERIENCED A TRANSFUSION REACTION AFTER RECEIVING 12 UNITS OF PACKED RED BLOOD CELLS, ONE OF WHICH WAS POSITIVE FOR THE KELL ANTIGEN. PRE-TRANSFUSION TESTING FOR UNEXPECTED ANTIBODIES DID NOT DETECT ANTI-K IN THE PT'S SAMPLE. THE PT WAS DISCHARGED 3 DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREENING CELLS TRIO IN-VITRO DIAGNOSTIC KSZ GAMMA BIOLOGICALS, INC. NA 0212845

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other