BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-ID

    MDR report key: 5695057 · Received June 2, 2016

    Report

    Report Number
    1034569-2016-00120
    Event Type
    Malfunction
    Date Received
    June 2, 2016
    Date of Event
    May 4, 2016
    Report Date
    June 2, 2016
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    UDI-DI
    10888234001188
    PMA / PMN Number
    102707/0.0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE PI LAB CONFIRMED THE REACTIVITY OF THE E ANTIGEN ON CELLS 1, 3, AND 6 OF RETENTION CAPTURE-R READY-ID, LOT ID296, IN MANUAL CAPTURE, USING RETENTION CAPTURE-R READY INDICATOR RED CELL, LOT 221624 WITH ANTI-E, LOT TN0034. CONTROLS PERFORMED AS EXPECTED AND ALL CELL EXHIBITED THE EXPECTED REACTIVITY. RETENTION PERFORMED AS EXPECTED. A SERVICE CALL WAS MADE AND THE INSTRUMENT WAS FOUND TO BE WITHIN SPECIFICATIONS. OUR INVESTIGATION DID NOT IDENTIFY A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    ON (B)(6) 2016, A CUSTOMER REPORTED UNEXEPCTED NEGATIVE WITH CAPTURE-R READY-ID ON THE GALILEO ECHO INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351280 CAPTURE-R READY-ID REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. ID296 10888234001188

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR