BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTIME MICROCOAGULATION SYSTEM

    MDR report key: 1881359 · Received October 7, 2010

    Report

    Report Number
    2248721-2010-00146
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Date of Event
    September 2, 2010
    Report Date
    September 17, 2010
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    GKP
    PMA / PMN Number
    K951072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MANUFACTURER AWAITING PRODUCT RETURN FOR FURTHER COMPLAINT EVALUATION.

    Description of Event or Problem · 1

    PATIENT SELF TESTER REPORTS: PROTIME SYSTEM INR INCONSISTENT PATIENT RESULTS. ON (B)(6) 2010, PST PROTIME INR 1.4 VS 2.18 REFERENCE LAB. PATIENT'S INR THERAPEUTIC RANGE: 2.0 - 3.0. NO ADVERSE EVENT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1