BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTIME MICROCOAGULATION SYSTEM

    MDR report key: 2473929 · Received February 20, 2012

    Report

    Report Number
    2248721-2012-00017
    Event Type
    Malfunction
    Date Received
    February 20, 2012
    Date of Event
    January 1, 2012
    Report Date
    January 25, 2012
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    GJS
    PMA / PMN Number
    K961835
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER PROVIDED CUVETTE LOTS LIK3H454 AND JIK3H386. METHOD: ACTUAL DEVICE NOT EVALUATED. CUVETTE DEVICE HISTORY RECORDS REVIEWED AND FOUND TO MEET SPECS. NO RELATED NCMRS, COMPLAINT TRENDS, OR CAPA IDENTIFIED. RESULT: NO RESULTS AVAILABLE SINCE NO EVAL PERFORMED. CONCLUSION: UNABLE TO CONFIRM COMPLAINT. DEVICE NOT RETURNED. ITC HAS REQUESTED ALL DATA REQUIRED FOR FORM 3500A.

    Description of Event or Problem · 1

    PT SELF-TESTER REPORTS INCONSISTENT RESULTS WITH THE PROTIME MICROCOAGULATION SYSTEM. ON (B)(6) 2012, PROTIME TEST GENERATED INR 3.7 AND RETEST AT CLINIC THE NEXT DAY GENERATED INR 2.3. CUSTOMER F/U ON (B)(6) 2012 REPORTS TEST PERFORMED AT PHYSICIAN'S OFFICE GENERATED INR 3.2 AND ON THE SAME DAY PROTIME TEST GENERATED INR 1.2. PT'S THERAPEUTIC RANGE: 2.5-3.5. NO ADVERSE EVENT(S) REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1