BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-CMV INDICATOR CELLS

    MDR report key: 2260041 · Received September 22, 2011

    Report

    Report Number
    1034569-2011-00141
    Event Type
    Malfunction
    Date Received
    September 22, 2011
    Date of Event
    August 23, 2011
    Report Date
    September 22, 2011
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    K910003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT IMAGE FILES FROM THE (B)(6) WERE REVIEWED BY AN IMMUCOR TECHNICAL SUPPORT SPECIALIST. VISUALLY THE SAMPLE APPEARED (B)(6), CORRELATING WITH THE REPORTED RESULT. NO ERRORS WERE NOTED IN THE EVENT LOG. IN-HOUSE TESTING WAS PERFORMED WITH RETENTION PRODUCT. THE CMV ASSAY WAS PERFORMED ON 3 KNOWN CMV NEGATIVE IN HOUSE DONORS ON THE (B)(6) USING RETENTION CAPTURE-CMV TEST WELLS, LOT C089, AND CAPTURE-CMV INDICATOR CELLS, LOT 228154. CONTROLS PERFORMED AS EXPECTED. ALL THREE KNOWN CMV NEGATIVE IN HOUSE DONORS REPORTED NEGATIVE AS EXPECTED. RETENTION PRODUCT PERFORMED AS EXPECTED. THE CMV ASSAY WAS PERFORMED ON THE CUSTOMERS SUBMITTED DONOR SAMPLE ON THE GALILEO USING RETENTION PRODUCTS CAPTURE-CMV TEST WELLS, LOT C089, AND CAPTURE-CMV INDICATOR CELLS, LOT 228154. CONTROLS PERFORMED AS EXPECTED. CUSTOMERS SAMPLE REPORTED (B)(6). THE UNEXPECTED POSITIVE RESULTS APPEAR TO BE SAMPLE RELATED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED UNEXPECTED (B)(6) REACTIONS WITH A DONOR SAMPLE THAT IS HISTORICALLY (B)(6) NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-CMV INDICATOR CELLS SOLID PHASE SYSTEM FOR DETECTION OF IGG AND IGM ANTIBODIES TO CYTOMEGALOVIRUS KSZ IMMUCOR, INC. 228154

    Patients

    Seq Age Sex Outcome Treatment
    1