BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTIME MICROCOAGULATION SYSTEM

    MDR report key: 1860311 · Received September 23, 2010

    Report

    Report Number
    2248721-2010-00135
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    September 3, 2010
    Report Date
    September 23, 2010
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    GKP
    PMA / PMN Number
    K951072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MANUFACTURER AWAITING PRODUCT RETURN FOR FURTHER COMPLAINT EVALUATION.

    Description of Event or Problem · 1

    HEALTHCARE PROVIDER REPORTS: PROTIME SYSTEM PT/INR RESULTS LOWER THAN REFERENCE LAB. PATIENT 2 OF 6 DATA COMPARISONS: ON (B)(6) 2010, PROTIME INSTRUMENT PT/INR WAS 1.5 VERSUS REFERENCE LAB RESULT INR 2.4. PT/INR TARGET RANGE: 2.0-3.0. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTIME MICROCOAGULATION SYSTEM PROTIME INSTRUMENT GKP INTERNATIONAL TECHNIDYNE CORP. PROTIMEPRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1