BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMOCHRON ELITE MICROCOAGULATION SYSTEM

    MDR report key: 1328080 · Received February 27, 2009

    Report

    Report Number
    2248721-2009-00059
    Event Type
    Injury
    Date Received
    February 27, 2009
    Date of Event
    February 9, 2009
    Report Date
    February 26, 2009
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORPORATION
    Product Code
    JPA
    PMA / PMN Number
    K940432
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S EVALUATION / INVESTIGATION CURRENTLY IN PROCESS.

    Description of Event or Problem · 1

    CUSTOMER REPORTS INCONSISTENT INR RESULTS FOR 3 PATIENTS USING HEMOCHRON ELITE INSTRUMENT / PT ASSAY COMPARED TO UNSPECIFIED LAB INSTRUMENT. THIS REPORT IS FOR PATIENT 2 OF 3. IN 2009, PATIENT ELITE / PT INR 7.2 VS. 4.99 INR ON UNSPECIFIED LAB INSTRUMENT. NO REPORT OF ANY ADVERSE EVENT, SERIOUS INJURY, OR INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOCHRON ELITE MICROCOAGULATION SYSTEM ELITE INSTRUMENT / PT CUVETTE ASSAY JPA INTERNATIONAL TECHNIDYNE CORPORATION ELITE F8JPT047

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other