BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTIME MICROCOAGULATION SYSTEM

    MDR report key: 2321434 · Received October 19, 2011

    Report

    Report Number
    2248721-2011-00124
    Event Type
    Malfunction
    Date Received
    October 19, 2011
    Date of Event
    September 12, 2011
    Report Date
    September 23, 2011
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORPORATION
    Product Code
    GKP
    PMA / PMN Number
    K951072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE HAS BEEN REQUESTED. NO PRODUCT RECEIVED. DEVICE HISTORY RECORD WAS REVIEWED. NO NCMRS, COMPLAINT TRENDS OR RELATED CAPA IDENTIFIED. RECORD EVALUATION COMPLETED. PRODUCT MET RELEASE CRITERIA. COMPLAINT COULD NOT BE CONFIRMED. ITC HAS REQUESTED ALL DATA REQUIRED FOR FORM 3500A.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTS RESULTS HIGHER THAN REFERENCE WITH PROTIME MICRCOAGULATION SYSTEM. ON (B)(6) 2011 THE PT STARTED LOW MOLECULAR WEIGHT HEPARIN. INR RESULT ON (B)(6) 2011 WAS 2.0. THE LAB SAMPLE 30 MINS LATER GENERATED INR 1.4. PT'S THERAPEUTIC RANGE WAS NOT PROVIDED. THIS EVENT OCCURRED OUTSIDE THE UNITED STATES DURING THE COURSE OF A (B)(4) STUDY. THE PROTIME PACKAGE INSERT INDICATES IN THE "LIMITATIONS" SECTION THAT "RESULTS MAY BE AFFECTED IN PTS RECEIVING HEPARIN OR WHO HAVE AN ABNORMAL RESPONSE TO HEPARIN". NO ADVERSE EVENT(S) REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTIME MICROCOAGULATION SYSTEM GKP INTERNATIONAL TECHNIDYNE CORPORATION PROPH220

    Patients

    Seq Age Sex Outcome Treatment
    1 CLEXANE (ENOXAPARIN)