BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOCHRON JR. SIGNATURE PLUS SYSTEM

    MDR report key: 2172197 · Received June 15, 2011

    Report

    Report Number
    2248721-2011-00071
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Report Date
    May 18, 2011
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    JPA
    PMA / PMN Number
    K020798
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD - DEVICE HISTORY RECORD REVIEWED FOR NCMR AND CAPA. ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED. RESULT - CUSTOMER COMPLAINT COULD NOT BE CONFIRMED. CONCLUSION - 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 EXPECTED ACT-LR RESULTS DURING CATHETERIZATION PROCEDURE WITH HEMOCHRON JR. SIGNATURE PLUS SYSTEM. CUSTOMER REPORTED "ACT IN LOW 200S." A SECOND PSIG WAS BROUGHT IN, SAMPLE WAS RUN AND GENERATED EXPECTED RESULTS. PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. LIQUID QUALITY CONTROLS WERE ACCEPTABLE ON BOTH INSTRUMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOCHRON JR. SIGNATURE PLUS SYSTEM JPA INTERNATIONAL TECHNIDYNE CORP. PSIG

    Patients

    Seq Age Sex Outcome Treatment
    1