BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOCHRON RESPONSE COAGULATION SYSTEM

    MDR report key: 1657238 · Received April 7, 2010

    Report

    Report Number
    2248721-2010-00066
    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 Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    HEALTH CARE PROFESSIONAL: REPORTS THAT DURING TESTING WITH HEMOCHRON RESPONSE, THE BLOOD SUCCESSFULLY CLOTTED BUT THE VALUE WENT UP AND PASSED 1500 SEC. THE DOCTOR PUT THE HEPARIN TO 350 SEC BUT THE VALUE WENT UP CONTINUOUSLY AND PASSED 1500 SEC. PT RESULT HIGHER THAN REFERENCE/EXP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOCHRON RESPONSE COAGULATION SYSTEM HEMOCHRON RESPOSNE COAGULATION ANALYZER KQG INTERNATIONAL TECHNIDYNE CORP. HRS.220

    Patients

    Seq Age Sex Outcome Treatment
    1