BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    H-TRONPLUS

    MDR report key: 715290 · Received May 10, 2006

    Report

    Report Number
    2183996-2006-00307
    Event Type
    Malfunction
    Date Received
    May 10, 2006
    Date of Event
    April 17, 2006
    Report Date
    May 5, 2006
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS, INC.
    Product Code
    LZG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    INFUSION DEVICE WOULD NOT DISPENSE INSULIN. PATIENT INDICATED THAT HE WAS EXPERIENCING ELEVATED BLOOD GLUCOSE (200 - 497 MG/DL). PATIENT INDICATED THAT HE WAS ABLE TO MANUALLY PUSH INSULIN FROM THE CARTRIDGE, BUT THE DEVICE WOULD NOT PUSH IT OUT. PATIENT INDICATED THAT HE SWITCHED TO BACKUP DEVICE AND EVERYTHING WAS OK.

    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 36 YR