BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOCHRON RESPONSE COAGULATION SYSTEM

    MDR report key: 3823749 · Received February 20, 2014

    Report

    Report Number
    2248721-2014-00007
    Event Type
    Malfunction
    Date Received
    February 20, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 21, 2014
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    JPA
    PMA / PMN Number
    K983475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ACT TUBE LOT # NOT PROVIDED. METHOD CODE: ACTUAL DEVICE NOT EVALUATED. NO RELATED COMPLAINT TRENDS IDENTIFIED. RESULT CODE: RESULTS PENDING COMPLETION OF EVALUATION. CONCLUSION CODE: CONCLUSION NOT YET AVAILABLE - EVALUATION IN PROGRESS. ITC HAS REQUESTED ALL DATA REQUIRED FOR FORM 3500A.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSION REPORTS ACT RESULT LOWER THAN EXPECTED WITH THE HEMOCHRON RESPONSE COAGULATION SYSTEM. PT TEST PERFORMED ON THE HEMOCHRON RESPONSE INSTRUMENT GENERATED ACT RESULTS OF 453 SECONDS IN TEST WELL 1 AND 332 SECONDS IN TEST WELL 2. THE RESULT FROM TEST WELL 2 WAS LOWER THAN EXPECTED. A SECOND HEMOCHRON RESPONSE INSTRUMENT WAS USED FOR COMPARISON TESTING AND GENERATED RESULTS OF 461 AND 462 SECONDS, WHICH WAS AS EXPECTED. NO ADVERSE EVENT(S) REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106694 HEMOCHRON RESPONSE COAGULATION SYSTEM JPA INTERNATIONAL TECHNIDYNE CORP. HRS.RF

    Patients

    Seq Age Sex Outcome Treatment
    1