BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D-TRON PLUS

    MDR report key: 656973 · Received December 23, 2005

    Report

    Report Number
    2183996-2005-00551
    Event Type
    Malfunction
    Date Received
    December 23, 2005
    Date of Event
    December 20, 2005
    Report Date
    December 22, 2005
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PATIENT REPORTED ELEVATED BLOOD GLUCOSE, 140-200 MG/DL (NORMAL = 85-115) OVER THE LAST 10 DAYS. PATIENT STATED HE HAS NO EXPLANATION FOR THE ELEVATED LEVELS, EXCEPT THAT HE FEELS THE DEVICE CAUSED THEM. PATIENT STATED HE ALSO RECEIVED AN E6 ERROR (MECHANICAL ERROR).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 D-TRON PLUS INSULIN INFUSION PUMP LZG DISETRONIC MEDICAL SYSTEMS D-TRONPLUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR