BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTIME MICROCOAGULATION SYSTEM

    MDR report key: 2497092 · Received March 13, 2012

    Report

    Report Number
    2248721-2012-00031
    Event Type
    Malfunction
    Date Received
    March 13, 2012
    Date of Event
    January 1, 2012
    Report Date
    February 22, 2012
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    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). CUVETTE LOT # NOT PROVIDED. ACTUAL DEVICE EVALUATED. PROCESS EVALUATION PERFORMED. NO RELATED NCMRS, COMPLAINT TRENDS OR CAPA IDENTIFIED. NO FAILURE DETECTED. 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. PROTIME GENERATED 1.4 INR AND LAB GENERATED RESULT OF 2.9 INR. EXPECTED INR RANGE 2.0 - 3.0. NO ADVERSE EVENT(S) REPORTED. THE EVENT OCCURRED DURING THE COURSE OF A PHARMACEUTICAL CLINICAL STUDY. UNABLE TO CONFIRM IF PT WAS ON WARFARIN OR TAKING THE STUDY DRUG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTIME MICROCOAGULATION SYSTEM GKP INTERNATIONAL TECHNIDYNE CORP. PROPH110

    Patients

    Seq Age Sex Outcome Treatment
    1