BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTIME MICROCOAGULATION SYSTEM

    MDR report key: 2181451 · Received July 6, 2011

    Report

    Report Number
    2248721-2011-00083
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 13, 2011
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    GKP
    PMA / PMN Number
    K951072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: DEVICE HISTORY RECORD REVIEWED FOR NCMR. ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED. RESULT: RECORD EVALUATION COMPLETED. COMPLAINT COULD NOT BE CONFIRMED. DEVICE PERFORMED ACCORDING TO SPECIFICATIONS. CONCLUSION: DEVICE EVALUATED AND ALLEGED FAILURE COULD NOT BE DUPLICATED. ITC HAS REQUESTED ALL DATA REQUIRED FOR FORM 3500A.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTS LOWER THAN EXPECTED RESULTS ON PROTIME MICROCOAGULATION SYSTEM. THE TEST WAS REPEATED IMMEDIATELY AND OBTAINED DIFFERENT RESULT THAN THE FIRST. PATIENT GENERATED INR 1.5 THE TEST WAS REPEATED WITH A FRESH SAMPLE ON THE SAME INSTRUMENT AND GENERATED INR 2.2. THE TEST WAS REPEATED WITH A THIRD SAMPLE ON A SECOND INSTRUMENT AND GENERATED INR 2.3. THE INR 2.2 WAS USED FOR TREATMENT DECISION. 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. PROTIMEPRO

    Patients

    Seq Age Sex Outcome Treatment
    1 COUMADIN| LOVENOX