BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTIME MICROCOAGULATION SYSTEM

    MDR report key: 2465640 · Received February 8, 2012

    Report

    Report Number
    2248721-2012-00011
    Event Type
    Malfunction
    Date Received
    February 8, 2012
    Date of Event
    January 1, 2012
    Report Date
    January 12, 2012
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    GKP
    PMA / PMN Number
    P951072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUVETTE LOT NUMBER UNKNOWN. 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 LOWER THAN EXPECTED INR RESULTS WITH THE PROTIME MICROCOAGULATION SYSTEM. PROTIME GENERATED 1.9 INR AND LAB RESULT GENERATED 3.73 INR. LAB RESULT WAS CONSISTENT WITH THE PATIENT'S CLINICAL PRESENTATION AND TREATMENT WAS BASED ON THE LAB RESULT. NO ADDITIONAL INFORMATION REPORTED ON THE PATIENT. THERAPEUTIC RANGE WAS NOT PROVIDED. NO ADVERSE EVENT(S) REPORTED. THIS EVENT OCCURRED OUTSIDE OF THE UNITED STATES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1