BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANOSCREEN I, II, III

    MDR report key: 2125356 · Received June 15, 2011

    Report

    Report Number
    1034569-2011-00068
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    May 18, 2011
    Report Date
    June 15, 2011
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    STN 102707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENTS SAMPLE WAS NOT SUBMITTED FOR INVESTIGATION. THE PRESENCE OF THE ANTIGENS WAS CONFIRMED ON RETENTION PRODUCT PANOCELL-10, LOT 11765 AND PANOSCREEN I, II AND III, LOT 12778 WITH ANTI-C, LOT 936050 AND ANTI-S, LOT 622003-1 REAGENTS. CONTROLS PERFORMED AS EXPECTED AND REAGENT RED BLOOD CELLS EXHIBITED THE EXPECTED REACTIVITY. NO PRODUCT DEFICIENCIES WERE IDENTIFIED. THE PRODUCTS ARE PERFORMING AS EXPECTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIONS WITH IMMUCOR ANTIBODY SCREENING AND IDENTIFICATION CELLS ON A PATIENT SAMPLE CONTAINING ANTI-C AND ANTI-S.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PANOSCREEN I, II, III REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. 12778

    Patients

    Seq Age Sex Outcome Treatment
    1