BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOCHRON RESPONSE COAGULATION SYSTEM

    MDR report key: 1864821 · Received September 28, 2010

    Report

    Report Number
    2248721-2010-00140
    Event Type
    Malfunction
    Date Received
    September 28, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 28, 2010
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    JPA
    PMA / PMN Number
    K983475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ITC (B)(4). MANUFACTURER AWAITING ADDITIONAL INFORMATION FOR FURTHER COMPLAINT EVALUATION.

    Description of Event or Problem · 1

    HEALTHCARE PROVIDER REPORTS THE HEMOCHRON RESPONSE INSTRUMENT IS "NOT DETECTING A CLOT." CUSTOMER COULD NOT CONFIRM THAT AN ACTUAL CLOT HAD FORMED IN THE HEMOCHRON RESPONSE ASSAY TUBE. NO ADVERSE EVENT REPORTED. THIS EVENT OCCURRED OUTSIDE THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOCHRON RESPONSE COAGULATION SYSTEM HEMOCHRON RESPONSE COAGULATION ANALYZER JPA INTERNATIONAL TECHNIDYNE CORP. HRS.110 NA

    Patients

    Seq Age Sex Outcome Treatment
    1