BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-CMV

    MDR report key: 5643983 · Received May 10, 2016

    Report

    Report Number
    1034569-2016-00105
    Event Type
    Malfunction
    Date Received
    May 10, 2016
    Date of Event
    April 15, 2016
    Report Date
    May 10, 2016
    Manufacturer
    IMMUCOR, INC.
    Product Code
    LJO
    UDI-DI
    10888234001157
    PMA / PMN Number
    K910003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    NO ELECTRONIC CONNECTION METHOD FOR MANUAL CAPTURE WORKSTATION WAS AVAILABLE, FOR USE BY IMMUCOR TECHNICAL SUPPORT. THE BLOOD SAMPLE WAS FROM A DONOR, AND FURTHER TESTING WAS NOT POSSIBLE BECAUSE THERE WAS NOT ENOUGH SAMPLE VOLUME REMAINING. NO EXTRA SAMPLE VOL TO CONTINUE TESTING.

    Description of Event or Problem · 1

    ON (B)(6) 2016, A CUSTOMER SITE REPORTED AN UNEXPECTEDLY POSITIVE CMV TEST WHEN USING CAPTURE-CMV ON A MANUAL CAPTURE WORKSTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300460 CAPTURE-CMV SOLID PHASE SYSTEM FOR DETECTION OF IGG AND IGM ANTIBODIES TO CYTOMEGALOVIRUS LJO IMMUCOR, INC. C121 10888234001157

    Patients

    Seq Age Sex Outcome Treatment
    1