BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOCHRON RESPONSE MICROCOAGULATION SYSTEM

    MDR report key: 1931928 · Received November 30, 2010

    Report

    Report Number
    2248721-2010-00172
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    November 11, 2010
    Report Date
    November 11, 2010
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    JPA
    PMA / PMN Number
    K983475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (METHOD, RESULTS, CONCLUSION): MANUFACTURER/ EVALUATION/ INVESTIGATION PENDING PRODUCT RETURN FROM USER FACILITY.

    Description of Event or Problem · 1

    CUSTOMER REPORTS HEMOCHRON RESPONSE TUBES FROM ONE LOT ONLY REACH AN ACT 200 SEC RESULT AND NOT THE EXPECTED ACT 400 SEC. HEMOCHRON RESPONSE TUBES FROM A DIFFERENT LOT REACHED 400 SEC ON THE SAME INSTRUMENT. NO ADVERSE EVENT WAS REPORTED. THIS EVENT OCCURRED OUTSIDE THE US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOCHRON RESPONSE MICROCOAGULATION SYSTEM HEMOCHRON RESPONSE TUBES JPA INTERNATIONAL TECHNIDYNE CORP. HRFTCA510 D9FTE100B

    Patients

    Seq Age Sex Outcome Treatment
    1