BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTIME MICROCOAGULATION SYSTEM

    MDR report key: 2505178 · Received March 20, 2012

    Report

    Report Number
    2248721-2012-00027
    Event Type
    Malfunction
    Date Received
    March 20, 2012
    Date of Event
    January 1, 2012
    Report Date
    February 21, 2012
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    GKP
    PMA / PMN Number
    K951072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUVETTE LOT NUMBER NOT PROVIDED BY CUSTOMER. METHOD: ACTUAL DEVICE NOT EVALUATED. PROCESS EVALUATION PERFORMED. NO RELATED NCMRS, COMPLAINT TRENDS, OR CAPA IDENTIFIED. RESULT: NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED. CONCLUSION: UNABLE TO CONFIRM COMPLAINT. DEVICE NOT RETURNED. ITC HAS REQUESTED ALL DATA REQUIRED FOR FORM 3500A.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTS RESULTS HIGHER THAN EXPECTED WITH THE PROTIME MICROCOAGULATION SYSTEM. PROTIME GENERATED INR RESULT 4.5 AND LAB GENERATED INR RESULT 1.8. PT TREATED BASED ON LAB RESULT. PT TESTED DAILY AND RESULTS NORMALLY RUN 1.9-2.0. PT'S THERAPEUTIC RANGE: 2.0-3.0. NO ADVERSE EVENT(S) REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1