BEUDAMED
    FDA Adverse Event Other Summary report: N

    PROTIME MICROCOAGULATION INSTRUMENT

    MDR report key: 1023518 · Received March 27, 2008

    Report

    Report Number
    2248721-2008-00012
    Event Type
    Other
    Date Received
    March 27, 2008
    Date of Event
    February 28, 2008
    Report Date
    March 27, 2008
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    GJS
    PMA / PMN Number
    K961835
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). MFR METHOD, RESULTS AND CONCLUSIONS - MFR CURRENTLY AWAITING PRODUCT RETURN FROM USER.

    Description of Event or Problem · 1

    SELF-TEST USER REPORTS PROTIME INR OF 2.4 AND 2.5, SUBSEQUENT LAB REFERENCE INR OF 3.6. USER ALSO REPORTS A COINCIDENT TIA WHICH WAS SELF-TREATED WITH ASPIRIN. NO HOSPITALIZATION OR INTERVENTIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTIME MICROCOAGULATION INSTRUMENT PROTIME INSTRUMENT GJS INTERNATIONAL TECHNIDYNE CORP. PROTIME NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other