BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTIME MICROCOAGULATION SYSTEM

    MDR report key: 3820625 · Received April 11, 2014

    Report

    Report Number
    2248721-2014-00015
    Event Type
    Malfunction
    Date Received
    April 11, 2014
    Date of Event
    January 1, 2014
    Report Date
    March 21, 2014
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    GJS
    PMA / PMN Number
    K961835
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR WHICH WAS SUBMITTED ON 04/10/2014 REFERENCES ITC COMPLAINT #(B)(4). MULTIPLE LOTS OF CUVETTES WERE USED; LOT NUMBERS WERE NOT PROVIDED. THE ACTUAL DEVICE WAS NOT EVALUATED. PROCESS EVALUATION WAS PERFORMED; NO RELATED NCRS WERE IDENTIFIED FOR THIS INSTRUMENT.

    Description of Event or Problem · 1

    A PT SELF-TESTER REPORTS THAT RESULTS GREATER THAN A REF INSTRUMENT WERE GENERATED WITH THE PROTIME MICROCOAGULATION SYSTEM. PT'S THERAPEUTIC RANGE: 2.3 - 2.5 INR. DURING A SIDE BY SIDE TEST, THE PT SELF-TESTER'S PROTIME INSTRUMENT GENERATED A RESULT OF 2.7 INR AND USING A REFERENCE PROTIME INSTRUMENT 2.0 INR WAS GENERATED. NO ADVERSE EVENTS WERE REPORTED; THE RESULTS GENERATED BY THE REFERENCE INSTRUMENT WERE USED FOR PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226095 PROTIME MICROCOAGULATION SYSTEM PROTHROMBIN TIME TEST GJS INTERNATIONAL TECHNIDYNE CORP. PROTIMERPL

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR