BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOCHRON ELITE MICROCOAGULATION SYSTEM

    MDR report key: 3810679 · Received March 24, 2014

    Report

    Report Number
    2248721-2014-00012
    Event Type
    Malfunction
    Date Received
    March 24, 2014
    Date of Event
    January 1, 2014
    Report Date
    March 7, 2014
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    JPA
    PMA / PMN Number
    K050016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL DEVICE WAS NOT YET EVALUATED; A PROCESS EVALUATION WAS PERFORMED. NO RELATED NCRS WERE IDENTIFIED FOR THIS INSTRUMENT. CUVETTE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO MEET SPECIFICATIONS. RESULTS PENDING COMPLETION OF EVALUATION. THE DEVICE WAS RETURNED AND EVALUATION IS IN PROGRESS; CONCLUSION NOT YET AVAILABLE. ITC HAS REQUESTED ALL DATA REQUIRED FOR FORM 3500A.

    Description of Event or Problem · 1

    A HEALTHCARE PROFESSIONAL REPORTS THAT LOWER THAN EXPECTED ACT+ RESULTS WERE GENERATED WITH THE HEMOCHRON SIGNATURE ELITE MICROCOAGULATION SYSTEM. THE PATIENT WAS ADMINISTERED 10,000 UNITS OF HEPARIN DURING AN ENDOGRAPH PROCEDURE. THE ELITE INSTRUMENT GENERATED AN ACT+ RESULT OF 162 SECONDS; THE EXPECTED RESULT FOR THIS PATIENT WAS 300 SECONDS. NO ADVERSE EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172557 HEMOCHRON ELITE MICROCOAGULATION SYSTEM JPA INTERNATIONAL TECHNIDYNE CORP. ELITE

    Patients

    Seq Age Sex Outcome Treatment
    1 ONE DAY BEFORE SURGERY.| THE PATIENT WAS ON PLAVIX AND DISCONTINUED IT,