BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTIME MICROCOAGULATION SYSTEM

    MDR report key: 1922092 · Received November 16, 2010

    Report

    Report Number
    2248721-2010-00169
    Event Type
    Malfunction
    Date Received
    November 16, 2010
    Date of Event
    October 18, 2010
    Report Date
    October 28, 2010
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORPORATION
    Product Code
    GJS
    PMA / PMN Number
    K961835
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR SUBMITTED (B)(4) 2010 REFERENCES ITC COMPLAINT (B)(4). METHOD, RESULT, CONCLUSION: MANUFACTURER/EVAL/INVESTIGATION PENDING PRODUCT RETURN FROM USER FACILITY.

    Description of Event or Problem · 1

    PT SELF-TESTER REPORTS: INSTRUMENT TAKES A LONG TIME TO GIVE RESULTS, NOISY, AND THE PROTIME SYSTEM INR RESULTS HIGHER THAN REFERENCE LAB. PROTIME INR 8.0 VS REFERENCE LAB INR 2.0 ON SAME DAY. INR TARGET RANGE: 3.5-4.0. NO ADVERSE EVENTS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1