BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-SCREEN (I AND II)

    MDR report key: 2991413 · Received March 6, 2013

    Report

    Report Number
    1034569-2013-00045
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    January 28, 2013
    Report Date
    March 6, 2013
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    STN 102707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL REVIEW OF RESULTS FOR INITIAL TESTING ON (B)(4) 2013, SHOWED THAT CELL 1, WHICH RESULTED AS NEGATIVE, HAD A LOOSE NEGATIVE BUTTON WITH A SLIGHTLY RED BACKGROUND. CELL 1 IS POSITIVE FOR THE KELL ANTIGEN. REPEAT TESTING ON THE GALILEO WAS PERFORMED BY THE CUSTOMER USING A DIFFERENT LOT OF TEST WELLS. THE EXPECTED POSITIVE RESULTS WERE OBTAINED. NO ADDITIONAL TESTING COULD BE PERFORMED DUE LOT X374 EXPIRING. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND THERE WERE NO DEFICIENCIES IDENTIFIED. THE PRODUCT PERFORMED AS EXPECTED UPON RELEASE.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED OBTAINING UNEXPECTED NEGATIVE REACTIONS WITH CAPTURE-R READY-SCREEN (I AND II), LOT X374, ON THE GALILEO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95559 CAPTURE-R READY-SCREEN (I AND II) REAGENT RED BLOOD CELL KSZ IMMUCOR, INC. X374

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR