BEUDAMED
    FDA Adverse Event Other Summary report: N

    SCREENING CELLS TRIO

    MDR report key: 405222 · Received July 11, 2002

    Report

    Report Number
    1623424-2002-00003
    Event Type
    Other
    Date Received
    July 11, 2002
    Date of Event
    June 12, 2002
    Report Date
    July 10, 2002
    Manufacturer
    GAMMA BIOLOGICALS, INC.
    Product Code
    KSZ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2002, THE PT EXPERIENCED A TRANSFUSION REACTION AFTER RECEIVING 2 UNITS OF PACKED RED BLOOD CELLS. THE PT'S BILIRUBIN WAS IN THE TEENS AND URINE WAS BLOODY. PRE-TRANSFUSION TESTING FOR UNEXPECTED ANTIBODIES DID NOT DETECT ANTI-K IN THE PATIENT'S SAMPLE. THE PT IS CURRENTLY STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREENING CELLS TRIO IN-VITRO DIAGNOSTIC KSZ GAMMA BIOLOGICALS, INC. NA 0507993

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other