BEUDAMED
    FDA Adverse Event Injury Summary report: N

    H-TRONPLUS

    MDR report key: 829459 · Received March 14, 2007

    Report

    Report Number
    2183996-2007-00283
    Event Type
    Injury
    Date Received
    March 14, 2007
    Date of Event
    February 20, 2007
    Report Date
    February 20, 2007
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS, INC.
    Product Code
    LZG
    PMA / PMN Number
    K023471
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT SHE WAS EXPERIENCING 01 (CARTRIDGE EMPTY) ALERTS EVEN THOUGH HER INSULIN CARTRIDGE WAS FULL. SHE STATED THAT HER BLOOD GLUCOSE LEVELS WERE ELEVATED BETWEEN 180-458 MG/DL. THE PT INDICATED THAT SHE WAS NOT FEELING WELL AT THE TIME OF THE CALL. DURING TROUBLESHOOTING, THE PATIENT ATTEMPTED TO RESET THE DEVICE BUT COULD NOT CLEAR THE ALARM. IT WAS DISCOVERED THAT THE BATTERY COMPARTMENT CONTAINED CORROSION AND THE DEVICE WAS MISSING SEGMENTS ON THE DISPLAY. THE PT REPORTED THAT SHE HAD BEEN SWIMMING AND BATHING WITH THE DEVICE FOR YEARS. THE PATIENT WAS EDUCATED TO AVOID WATER CONTACT. THE PATIENT SWITCHED TO A DIFFERENT INFUSION DEVICE. IN 2007, THE PT REPORTED THAT HER BLOOD GLUCOSE WAS BETTER. THE PRODUCT WAS REQUESTED TO BE RETURNED FOR EVALUATION.

    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 72 YR Required Intervention INSULIN| INSULIN INFUSION SET