BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTIME MICROCOAGULATION SYSTEM

    MDR report key: 1963404 · Received December 20, 2010

    Report

    Report Number
    2248721-2010-00176
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Report Date
    November 22, 2010
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    GJS
    PMA / PMN Number
    K951072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PURPOSE OF THIS MDR IS TO REPORT DISCREPANT PT INR RESULTS. "INR HIGH" USER MESSAGE INDICATES INR MEASURED GREATER THAN 12.0 VS REFERENCE LAB VALUE OF 2.6. (METHOD, RESULT, CONCLUSION): MANUFACTURER/EVALUATION/INVESTIGATION PENDING PRODUCT RETURN FROM USER FACILITY. NO CONCLUSION CAN BE DRAWN. (B)(4). MDR#: 2248721-2010-00175. ITC HAS REQUESTED ALL DATA REQUIRED FOR FORM 3500A. FIELDS FOR WHICH DATA WERE NOT OBTAINABLE OR ARE NOT APPLICABLE ARE INTENTIONALLY LEFT BLANK.

    Description of Event or Problem · 1

    HEALTH CARE PROFESSIONAL REPORTS "INR HIGH" USER MESSAGE INTERMITTENTLY DISPLAYED ON THEIR PROTIME MICROCOAGULATION SYSTEM. INITIAL TEST WITH THEIR INSTRUMENT GENERATED "INR HIGH"; PATIENT WAS RETESTED WITH A SECOND INSTRUMENT, RESULT WAS PT INR 2.6. THERAPEUTIC RANGE WAS NOT PROVIDED. PT INR 2.6 WAS USED TO DETERMINE TREATMENT. NO ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTIME MICROCOAGULATION SYSTEM PROTIME INSTRUMENT GJS INTERNATIONAL TECHNIDYNE CORP. L11-01-01C

    Patients

    Seq Age Sex Outcome Treatment
    1