BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOCHRON RESPONSE COAGULATION SYSTEM

    MDR report key: 2012164 · Received February 1, 2011

    Report

    Report Number
    2248721-2011-00022
    Event Type
    Malfunction
    Date Received
    February 1, 2011
    Report Date
    January 20, 2011
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    JPA
    PMA / PMN Number
    K983475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MANUFACTURER/EVALUATION/INVESTIGATION IN PROCESS. 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 THAT HEMOCHRON RESPONSE COAGULATION SYSTEM GENERATED LOWER THAN EXPECTED ACT RESULTS. THE TEST WAS REPEATED ON A SECOND INSTRUMENT AND RESULT WAS MORE IN LINE WITH WHAT THE OPERATOR EXPECTED. THERE WAS NO DELAY IN THE PROCEDURE. ELECTRIC QUALITY CONTROL AND WET QUALITY CONTROL ON THE INSTRUMENT PASSED. NO ADVERSE EVENT(S) REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOCHRON RESPONSE COAGULATION SYSTEM JPA INTERNATIONAL TECHNIDYNE CORP. HRS.110

    Patients

    Seq Age Sex Outcome Treatment
    1