BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTIME MICROCOAGULATION SYSTEM

    MDR report key: 2485668 · Received March 7, 2012

    Report

    Report Number
    2248721-2012-00028
    Event Type
    Malfunction
    Date Received
    March 7, 2012
    Date of Event
    February 6, 2012
    Report Date
    February 8, 2012
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    GKP
    PMA / PMN Number
    K951072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER PROVIDED CUVETTE LOT NUMBER K1P3C414. METHOD: ACTUAL DEVICE EVALUATED (INSTRUMENT). CUSTOMER RETURNED SAMPLES TESTED (SINGLE-USE DISPOSABLE). PROCESS EVALUATION PERFORMED. NO RELATED NCMRS, COMPLAINT TRENDS OR CAPA IDENTIFIED. RESULTS: NO FAILURE DETECTED. CONCLUSIONS: UNABLE TO CONFIRM COMPLAINT. NO FAILURE DETECTED, DEVICE OPERATED WITHIN SPECIFICATION. ITC HAS REQUESTED ALL DATA REQUIRED FOR FORM 3500A.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTS RESULTS LOWER THAN REFERENCE WITH THE PROTIME MICROCOAGULATION SYSTEM. HOME HEALTH NURSE TESTED PATIENT WITH PROTIME AND GENERATED INR RESULT 1.2. ON THE SAME DAY PATIENT TEST PERFORMED AT PHYSICIAN'S OFFICE GENERATED INR RESULT 2.2. PATIENT'S THERAPEUTIC RANGE: 2.0-3.0. NO ADVERSE EVENT(S) REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1