BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY SCREEN IV

    MDR report key: 1163436 · Received September 19, 2008

    Report

    Report Number
    1034569-2008-00451
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    August 22, 2008
    Report Date
    September 11, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    102707 STN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S RETURNED SAMPLES WERE TESTED WITH THE RETENTION CRRS(4), LOT. K152, ON AN IN-HOUSE GALILEO. POSITIVE REACTIONS WERE OBSERVED IN CELL 4, POSITIVE FOR ANTI-KELL. THE RETURNED SAMPLES WERE ALSO TESTED WITH THE RETENTION CRRID, LOT ID092, POSITIVE REACTIONS WERE OBSERVED FOR ANTI-KELL.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT FOR ONE DONOR SAMPLE AND ONE PATIENT SAMPLE, CAPTURE-R READY SCREEN (CRRS) IV LOT K152, MISSED THE REACTION WITH AN ANTI-KELL, WHEN TESTED ON GALILEO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY SCREEN IV REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. K152

    Patients

    Seq Age Sex Outcome Treatment
    1