BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTIME MICROCOAGULATION SYSTEM

    MDR report key: 2443651 · Received January 24, 2012

    Report

    Report Number
    2248721-2012-00001
    Event Type
    Malfunction
    Date Received
    January 24, 2012
    Date of Event
    December 1, 2011
    Report Date
    December 27, 2011
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    GJS
    PMA / PMN Number
    K961835
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUVETTE LOT NUMBER WAS NOT PROVIDED. ACTUAL DEVICE NOT EVALUATED. PROCESS EVAL PERFORMED. NO RELATED NCMRS, COMPLAINT TRENDS OR CAPA IDENTIFIED. ITC HAS REQUESTED ALL DATA REQUIRED FOR FORM 3500A.

    Description of Event or Problem · 1

    A HEALTHCARE PROFESSIONAL REPORTS PT SELF-TESTER GENERATED INR 1.8 ON PROTIME MICROCOAGULATION SYS AND ON THE SAME DAY LAB RESULTS GENERATED INR 2.9. ADD'L COMPARISON TEST GENERATED INR 1.9 ON PROTIME MICROCOAGULATION SYS AND LAB RESULTS GENERATED INR 2.9. 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