BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE R READY SCREEN I AND II

    MDR report key: 1222643 · Received November 10, 2008

    Report

    Report Number
    1034569-2008-00549
    Event Type
    Malfunction
    Date Received
    November 10, 2008
    Date of Event
    October 20, 2008
    Report Date
    November 7, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    102707 STN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE REACTIVITY OF THE C ANTIGEN WAS CONFIRMED ON RETURNED CRRS, LOT W145 USING RETURNED CRIRC, LOT 221263.THE CUSTOMER RETURNED SAMPLE, BUT THERE WAS NO PLASMA IN THE TUBE, CELLS ONLY; THEREFORE, TESTING COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    AN ANTI-C WAS NOT DETECTED ON A PATIENT SAMPLE TESTED WITH CAPTURE R READY SCREEN I AND II (CRRS) AND CAPTURE R INDICATOR CELLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE R READY SCREEN I AND II REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. W145

    Patients

    Seq Age Sex Outcome Treatment
    1