BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTIME MICROCOAGULATION SYSTEM

    MDR report key: 2191903 · Received July 22, 2011

    Report

    Report Number
    2248721-2011-00090
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Report Date
    June 28, 2011
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    GJS
    PMA / PMN Number
    K951072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR SUBMITTED (B)(4) 2011 REFERENCES ITC (B)(4) (CUVETTE LOT # A1P3C005). METHOD: ACTUAL DEVICE INVOLVED IN INCIDENT EVALUATED. INSTRUMENT DEVICE HISTORY RECORD REVIEWED AND DEVICE HISTORY RECORD FOR CUVETTE LOT WAS ALSO REVIEWED. THERE ARE NO NCRS AND INSTRUMENT AND CUVETTE MET ALL QC SPECS. THERE WERE NO COMPLAINT TRENDS OR RELATED CAPA/NCRS IDENTIFIED. RESULTS: RECORD EVAL COMPLETED. DEVICE OPERATED ACCORDING TO SPECS. COMPLAINT COULD NOT BE CONFIRMED. CONCLUSIONS: DEVICE EVALUATED AND ALLEGED FAILURE COULD NOT BE DUPLICATED. 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

    A HEALTHCARE PROFESSIONAL REPORTS PT SELF-TESTER GENERATED DISCREPANT RESULTS WITH PROTIME MICROCOAGULATION SYSTEM. PROTIME GENERATED INR 3.9 AND LAB GENERATED INR 2.4. THE PT'S THERAPEUTIC RANGE INR 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