BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOCHRON RESPONSE COAGULATION SYSTEM

    MDR report key: 1628963 · Received March 10, 2010

    Report

    Report Number
    2248721-2010-00023
    Event Type
    Malfunction
    Date Received
    March 10, 2010
    Report Date
    March 9, 2010
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    KQG
    PMA / PMN Number
    K983475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MANUFACTURER'S EVALUATION CURRENTLY IN PROCESS.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTS INCONSISTENT PATIENT RESULTS. HEMOCHRON RESPONSE SYSTEM CONSISTENTLY GIVING ACT RESULTS GREATER THAN 1500 SECONDS, ON MULTIPLE NON- HEPARINIZED PATIENTS. HEALTHCARE PROFESSIONAL DID NOT INDICATE NUMBER OF PATIENTS INVOLVED. NO REPORT OF ADVERSE EVENT, SERIOUS INJURY, OR INTERVENTION REPORTED. THIS EVENT OCCURRED IN A FOREIGN COUNTRY.

    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. RF C9FTE061A

    Patients

    Seq Age Sex Outcome Treatment
    1