BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY INDICATOR RED CELLS

    MDR report key: 3833762 · Received May 27, 2014

    Report

    Report Number
    1034569-2014-00082
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    April 30, 2014
    Report Date
    May 27, 2014
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK020053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IMMUCOR TECHNICAL SUPPORT ASSESSED TEST WELL IMAGES USING REMOTE ELECTRONIC CONNECTION METHOD ON (B)(4) 2014. IMMUCOR LABORATORY TESTED REAGENT RETENTION SAMPLES ON (B)(4) 2014 AND FOUND THAT THE RETENTION PRODUCT PERFORMED AS EXPECTED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE ANTIBODY SCREEN WHEN TESTING WITH CAPTURE-R READY INDICATOR RED CELLS ON A GALILEO ECHO INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310399 CAPTURE-R READY INDICATOR RED CELLS ANTI-HUMAN GLOBULIN KSZ IMMUCOR, INC. 221161

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR