BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-SCREEN (3)

    MDR report key: 4003902 · Received August 12, 2014

    Report

    Report Number
    1034569-2014-00144
    Event Type
    Malfunction
    Date Received
    August 12, 2014
    Date of Event
    July 16, 2014
    Report Date
    August 12, 2014
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    102707/5045
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IMMUCOR TECHNICAL SUPPORT ACCESSED THE CUSTOMER GALILEO ECHO INSTRUMENT TO VIEW THE TEST WELLS BY A REMOTE ELECTRONIC METHOD ON (B)(4) 2014. THE IMMUCOR PRODUCT INVESTIGATION LABORATORY TESTED THE RETENTION PRODUCT ON (B)(4) 2014 FOR E BLOOD GROUP ANTIGEN, AND THE PRODUCT PERFORMED AS EXPECTED. THE CUSTOMER RETURNED A BLOOD SAMPLE TO THE IMMUCOR LABORATORY FOR INVESTIGATION WHICH WAS TESTED AGAINST RETENTION PRODUCT (R442) ON (B)(4) 2014. THE CUSTOMER BLOOD SAMPLE RESULTED AS UNEXPECTED NEGATIVE WHEN TESTED BY THE IMMUCOR LABORATORY, WHICH DUPLICATED THE CUSTOMER OUTCOME AT THE CUSTOMER SITE.

    Description of Event or Problem · 1

    ON (B)(6) 2014, A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE ANTIBODY SCREEN WHEN USING CAPTURE-R READY-SCREEN (3) USING A GALILEO ECHO INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479964 CAPTURE-R READY-SCREEN (3) REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. R442

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR