BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTIME MICROCOAGULATION SYSTEM

    MDR report key: 1510706 · Received October 5, 2009

    Report

    Report Number
    2248721-2009-00567
    Event Type
    Malfunction
    Date Received
    October 5, 2009
    Date of Event
    July 2, 2009
    Report Date
    October 5, 2009
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    GKP
    PMA / PMN Number
    K961835
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MFR EVALUATION / INVESTIGATION PENDING PRODUCT RETURN.

    Description of Event or Problem · 1

    ORIGINALLY REPORTED TO (B)(4), PT SELF-TESTER REPORTS: PROTIME SYSTEM INR RESULTS BETWEEN 4.0, TWO DAYS LATER UNSPECIFIED LAB SYSTEM INR RESULT 10.0. PT WAS ADMINISTERED VITAMIN K. PT THERAPEUTIC RANGE 2.5 - 3.5 INR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTIME MICROCOAGULATION SYSTEM PROTIME INSTRUMENT GKP INTERNATIONAL TECHNIDYNE CORP. PROTIMEPST UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention