BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOCHRON RESPONSE COAGULATION SYSTEM

    MDR report key: 1626205 · Received February 11, 2010

    Report

    Report Number
    2248721-2010-00009
    Event Type
    Malfunction
    Date Received
    February 11, 2010
    Report Date
    February 11, 2010
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    KQG
    PMA / PMN Number
    K983475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INSTRUMENT WILL BE RETURNED TO MANUFACTURER AND AN EVALUATION OF THE COMPLAINT WILL BE CONDUCTED.

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL REPORTS OCCASIONALLY GETTING TESTS TIMES THAT GO LONGER THAN EXPECTED (CLOT NOT DETECTED BY HEMOCHRON RESPONSE INSTRUMENT) AND WHEN THEY PULL THE ASSAY TUBE IT HAS A CLOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOCHRON RESPONSE COAGULATION SYSTEM RESPONSE INST / ACT TUBE ASSAY KQG INTERNATIONAL TECHNIDYNE CORP. HRS.110

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other