BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOCHRON

    MDR report key: 5086431 · Received September 18, 2015

    Report

    Report Number
    5086431
    Event Type
    Malfunction
    Date Received
    September 18, 2015
    Report Date
    August 27, 2015
    Manufacturer
    ACCRIVA DIAGNOSTICS INC., DBA ITC, DBA ACCUMETRICS
    Product Code
    JPA
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WITH OR WITHOUT ANTICOAGULATION, PATIENTS' ACTIVATED CLOTTING TIMES (ACTS) IN THE CARDIAC CATH LAB AND ELECTROPHYSIOLOGY (EP) LABS ARE INCONSISTENT AND BELIEVED BY THE PHYSICIANS TO BE INACCURATE. THIS IS AN ONGOING PROBLEM ON MULTIPLE DATES OF SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618949 HEMOCHRON SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES JPA ACCRIVA DIAGNOSTICS INC., DBA ITC, DBA ACCUMETRICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NO OTHER THERAPIES