BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOCHRON JR SIGNATURE SYSTEM

    MDR report key: 1900234 · Received October 25, 2010

    Report

    Report Number
    2248721-2010-00136
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Date of Event
    September 13, 2010
    Report Date
    September 14, 2010
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    JPA
    PMA / PMN Number
    K974799
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: PRODUCT DEVICE HISTORY RECORD EVALUATED AND COMPLAINT NOT VERIFIED. RESULT: CUSTOMER COMPLAINT COULD NOT BE CONFIRMED. CONCLUSION: NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    HEALTH CARE PROVIDER REPORTS A HEMOCHRON JR SIGNATURE INSTRUMENT GAVE LOWER THAN REFERENCE/EXPECTED RESULTS. A LARGE AMOUNT OF HEPARIN (16,000 UNITS OUT OF 1000 UNITS/ML VIAL) WAS REQUIRED TO ACQUIRE AN ACT OF 231. NO ADVERSE EVENTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOCHRON JR SIGNATURE SYSTEM HEMOCHRON JR - SIGNATURE INSTRUMENT JPA INTERNATIONAL TECHNIDYNE CORP. HE-SIG NA

    Patients

    Seq Age Sex Outcome Treatment
    1