BEUDAMED
    FDA Adverse Event Other Summary report: N

    D-TRONPLUS

    MDR report key: 700921 · Received April 17, 2006

    Report

    Report Number
    2183996-2006-00171
    Event Type
    Other
    Date Received
    April 17, 2006
    Date of Event
    April 1, 2006
    Report Date
    April 13, 2006
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS, INC.
    Product Code
    LZG
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PT REPORTED NOTICING A WETNESS ON HIS SHIRT THEN EXPERIENCED ELEVATED BLOOD GLUCOSE (525 MG/DL). PT INDICATED THAT HE REPLACED THE INFUSION SET AND HIS BLOOD GLUCOSE RETURNED TO NORMAL. PT INDICATED THAT HE WAS UNSURE HOW THE INSULIN GOT ON HIS SHIRT. PT INDICATED THAT THE INFUSION SET TUBING WAS STILL CONNECTED AT THE TIME OF THE INCIDENT. PT INDICATED THAT THE CANNULA HAD PULLED OUT OF HIS BODY. PT WAS NOT RETURNING ANY PRODUCT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other