BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOCHRON RESPONSE, 110V

    MDR report key: 1575521 · Received December 17, 2009

    Report

    Report Number
    2248721-2009-00607
    Event Type
    Malfunction
    Date Received
    December 17, 2009
    Date of Event
    November 6, 2009
    Report Date
    December 17, 2009
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    KQG
    PMA / PMN Number
    K983475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MFR AWAITING PRODUCT RETURN FOR EVAL.

    Description of Event or Problem · 1

    INCONSISTENT TEST RESULTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOCHRON RESPONSE, 110V NONE KQG INTERNATIONAL TECHNIDYNE CORP. HRS.110 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR