BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTIME MICROCOAGULATION SYSTEM

    MDR report key: 2475667 · Received February 15, 2012

    Report

    Report Number
    2248721-2012-00007
    Event Type
    Malfunction
    Date Received
    February 15, 2012
    Date of Event
    January 1, 2012
    Report Date
    January 24, 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). THE CUVETTE LOT NUMBER WAS NOT PROVIDED. METHOD: ACTUAL DEVICE EVALUATED. PROCESS EVALUATION PERFORMED. NO RELATED NCMRS, COMPLAINT TRENDS OR CAPA IDENTIFIED. RESULT: NO FAILURE DETECTED. CONCLUSION: UNABLE TO CONFIRM COMPLAINT. NO FAILURE DETECTED, DEVICE OPERATED WITHIN SPECIFICATION. ITC HAS REQUESTED ALL DATA REQUIRED FOR FORM 3500A.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTS DISCREPANT RESULT ON PROTIME MICROCOAGULATION SYSTEM. PROTIME GENERATED INR RESULT 5.6. LAB GENERATED INR RESULT 3.0. PATIENT TREATED BASED ON LAB RESULT. PATIENT'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