BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-SCREEN (POOLED)

    MDR report key: 5698827 · Received June 3, 2016

    Report

    Report Number
    1034569-2016-00124
    Event Type
    Malfunction
    Date Received
    June 3, 2016
    Date of Event
    May 5, 2016
    Report Date
    June 3, 2016
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    UDI-DI
    10888234001959
    PMA / PMN Number
    102707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS ADVISED OF APPLICABLE LIMITATIONS IN THE PACKAGE INSERT: NEGATIVE REACTIONS WILL BE OBTAINED IF THE TEST SPECIMEN CONTAINS ANTIBODIES PRESENT IN CONCENTRATION TOO LOW TO BE DETECTED BY THE TEST METHODS EMPLOYED; ANTIBODY SCREENING TESTS EMPLOYING POOLED REAGENT RED BLOOD CELLS WILL NOT BE AS SENSITIVE AS THOSE INCORPORATING THE RED BLOOD CELLS OF UNPOOLED SINGLE DONORS.

    Description of Event or Problem · 1

    ON (B)(6) 2016, A CUSTOMER REPORTED OBTAINING UNEXPECTED NEGATIVE AND WEAK REACTIVITY RESULTS WITH CAPTURE-R READY SCREEN (POOLED) PLATES DURING VALIDATION ON GALILEO NEO (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354108 CAPTURE-R READY-SCREEN (POOLED) REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. N464 10888234001959

    Patients

    Seq Age Sex Outcome Treatment
    1