BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANOSCREEN I, II AND III

    MDR report key: 1695874 · Received May 21, 2010

    Report

    Report Number
    1034569-2010-00116
    Event Type
    Malfunction
    Date Received
    May 21, 2010
    Date of Event
    April 23, 2010
    Report Date
    May 19, 2010
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    PMA / PMN Number
    STN 102707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF RESULTS: PANOSCREEN LOT 05972 TESTED NEGATIVE FOR ALL 3 CELLS AT IGG PHASE CELL I (C+) CELL II (C-) CELL III (C-) TESTING PERFORMED BY REFERENCE LAB- PANOSCREEN LOT 09028 REACTED W+ FOR CELL I (C+), NEGATIVE FOR CELL II (C-), AND NEGATIVE FOR CELL III (C-) AT THE AHG PHASE. AN ANTI-E WAS DETECTED IN SOLID PHASE TESTING ON THE GALILEO. THE EVENTS APPEARS TO BE RELATED TO THE NATURE OF THE SAMPLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE RESULTS WHEN TESTING A SAMPLE WITH PANOSCREEN I, II AND III. ANTI-C WAS IDENTIFIED. WHEN THE SAMPLE WAS TESTED ON GALILEO, AN ANTI-E WAS ALSO DETECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PANOSCREEN I, II AND III REAGENT RED BLOOD CELLS KSZ IMMUCOR 09028

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR