BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-CMV

    MDR report key: 8057064 · Received November 9, 2018

    Report

    Report Number
    1034569-2018-00257
    Event Type
    Malfunction
    Date Received
    November 9, 2018
    Date of Event
    October 17, 2018
    Report Date
    November 9, 2018
    Manufacturer
    IMMUCOR, INC.
    Product Code
    LJO
    UDI-DI
    10888234001157
    PMA / PMN Number
    K910003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) WAS (B)(6) COMPARED TO DIASORON (B)(4). SAMPLE WAS DISCARDED BY CUSTOMER AND THEREFORE UNAVAILABLE FOR FURTHER INVESTIGATIONS TO BE ABLE TO REFEREE THE DIFFERENT OUTCOMES AND TO DEFINITIVELY DETERMINE CORRECT RESULT OUTCOME. ON (B)(6) 2018 PERFORMED A (B)(4) ASSAY ON SIX SAMPLES WITH KNOWN (B)(6) STATUS IN MANUAL CAPTURE USING RETENTION CAPTURE CMV PLATES LOT C133 AND RETENTION (B)(4) INDICATORS CELLS LOT 228331. CONTROLS PERFORMED AS EXPECTED AND ALL SAMPLES RESULTED AS EXPECTED. RETENTION PRODUCT PERFORMED AS EXPECTED. IMMUCOR CANNOT RULE OUT THE POSSIBILITY OF THE SPECIMEN BEING THE CAUSE OF UNEXPECTED (B)(6). (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2018 A CUSTOMER REPORTED UNEXPECTED (B)(6) RESULTS WITH (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    896878 CAPTURE-CMV CYTOMEGALOVIRUS ANTIBODY SCREEN LJO IMMUCOR, INC. C133 10888234001157

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Congenital Anomaly