BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOCHRON RESPONSE COAGULATION SYSTEM

    MDR report key: 1657235 · Received April 7, 2010

    Report

    Report Number
    2248721-2010-00069
    Event Type
    Malfunction
    Date Received
    April 7, 2010
    Report Date
    April 7, 2010
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    KQG
    PMA / PMN Number
    K983475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MANUFACTURER AWAITING MEDICAL DEVICE RETURN FROM CUSTOMER FOR EVAL.

    Description of Event or Problem · 1

    CUSTOMER REPORTS EXPERIENCING ALLEGEDLY FALSE CELITE ACT RESULTS (>1500 SECONDS). THE FALSE RESULTS WERE RANDOM AND IN BETWEEN A RANGE OF RESULTS OF 350-600 SECONDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOCHRON RESPONSE COAGULATION SYSTEM HEMOCHRON RESPONSE COAGULATION ANALYZER KQG INTERNATIONAL TECHNIDYNE CORP. HRS.RF

    Patients

    Seq Age Sex Outcome Treatment
    1