BEUDAMED
    FDA Adverse Event Injury Summary report: N

    H-TRONPLUS

    MDR report key: 642718 · Received October 21, 2005

    Report

    Report Number
    2183996-2005-00434
    Event Type
    Injury
    Date Received
    October 21, 2005
    Date of Event
    October 10, 2005
    Report Date
    October 10, 2005
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS, INC.
    Product Code
    LZG
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT REPORTED EXPERIENCING LOE BLOOD GLUCOSE (30-40 MG/DL, NORMAL = 70-150 MG/DL) WITH SEIZURES FOR THE PAST WEEK. PT IS A REGISTERED NURSE AND DID NOT RECEIVE MEDICAL TREATMENT. PT'S FAMILY MEMBER WOULD DISCONNECT DEVICE AND GIVE HER CARBOHYDRATE DRINKS. DURING TROUBLESHOOTING, IT WAS DETERMINED THAT THE PT IS USING THE INFUSION SET LONGER THAN RECOMMENDED. PT DID NOT KNOW THE AGE OF THE ADAPTER OR PISTON ROD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention