BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-ID

    MDR report key: 3983280 · Received August 6, 2014

    Report

    Report Number
    1034569-2014-00136
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    July 9, 2014
    Report Date
    August 6, 2014
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    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

    CUSTOMER PRODUCT AND PATIENT BLOOD SAMPLE WAS RETURNED TO IMMUCOR FOR IMMUCOR INVESTIGATION. THE RETURNED PRODUCT AND RETENTION PRODUCT PERFORMED AS EXPECTED ON (B)(6) 2014. THE RETURNED CUSTOMER BLOOD SAMPLE WAS ALSO EVALUATED ON (B)(6) 2014 USING RETENTION PRODUCT, FOR WHICH THE OUTCOMES DUPLICATED THE CUSTOMERS FINDINGS OF UNEXPECTED NEGATIVE ANTIBODY IDENTIFICATION. IMMUCOR TECHNICAL SUPPORT USED REMOTE ELECTRONIC ACCESS METHOD TO ASSESS INSTRUMENT TEST WELL IMAGES ON (B)(6) 2014.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459401 CAPTURE-R READY-ID REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. ID218

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR