BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTIME MICROCOAGULATION SYSTEM

    MDR report key: 1931618 · Received November 22, 2010

    Report

    Report Number
    2248721-2010-00171
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 13, 2010
    Report Date
    November 4, 2010
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    GJS
    PMA / PMN Number
    K961835
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    HEALTHCARE PROVIDER REPORTS: PROTIME SYSTEM INR RESULTS LOWER THAN REFERENCE LAB. PROTIME INR 1.4 VS LAB INR 2.58 ON SAME DAY. INR TARGET RANGE: 2.0 - 3.0. NO ADVERSE EVENTS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR