BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    H-TRONPLUS

    MDR report key: 676054 · Received February 10, 2006

    Report

    Report Number
    2183996-2006-00074
    Event Type
    Malfunction
    Date Received
    February 10, 2006
    Date of Event
    December 19, 2005
    Report Date
    February 8, 2006
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS, INC.
    Product Code
    LZG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PATIENT REPORTED ELEVATED BLOOD GLUCOSE (220 - 565 MG/DL). PATIENT INDICATED THAT SHE SWITCHED TO BACKUP DEVICE AND BLOOD GLUCOSE CAME DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 H-TRONPLUS INSULIN INFUSION PUMP LZG DISETRONIC MEDICAL SYSTEMS, INC. H-TRONPLUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR