BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOCHRON ELITE MICROCOAGULATION SYSTEM

    MDR report key: 2092970 · Received April 15, 2011

    Report

    Report Number
    2248721-2011-00056
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Report Date
    March 21, 2011
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORPORATION
    Product Code
    JPA
    PMA / PMN Number
    K050016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE HAS BEEN REQUESTED. NO PRODUCT RETURNED. CUSTOMER COMPLAINT COULD NOT BE CONFIRMED. NO CONCLUSION CAN BE DRAWN. ITC HAS REQUESTED ALL DATA REQUIRED FOR FORM 3500A.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTS LOWER THAN REFERENCE PT/ INR RESULTS WITH HEMOCHRON ELITE MICROCOAGULATION SYSTEM. THE TEST WAS REPEATED ON A LAB INSTRUMENT AND PT/INR RESULTS 3.2 GENERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOCHRON ELITE MICROCOAGULATION SYSTEM JPA INTERNATIONAL TECHNIDYNE CORPORATION ELITE

    Patients

    Seq Age Sex Outcome Treatment
    1