BEUDAMED
    FDA Adverse Event Injury Summary report: N

    D-TRONPLUS

    MDR report key: 1131945 · Received August 22, 2008

    Report

    Report Number
    2183996-2008-01269
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    August 7, 2008
    Report Date
    August 7, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS, INC.
    Product Code
    LZG
    PMA / PMN Number
    K043000
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PT REPORTED AN ELEVATED BLOOD GLUCOSE READINGS OF 378 MG/DL WITH HIS NORMAL RANGE BEING 138-154 MG/DL. HE STATED HE HAS JUST HAD SURGERY AND IS "DOWN AND OUT". TO TROUBLESHOOT, THE TIME AND BASAL RATE WERE CHECKED ON THE PT'S INSULIN INFUSION DEVICE AND CONFIRMED TO BE ACCURATE. THE PT WAS INSTRUCTED TO DISCONNECT FROM HIS DEVICE AND BOLUS 3 UNITS OF INSULIN INTO THE AIR WHICH WENT THROUGH WITHOUT ERROR. TROUBLESHOOTING DID NOT FIND ANY PRODUCT ISSUES. ON FOLLOW UP WITH THE PT FIVE DAYS LATER, HE STATED HIS READINGS ARE STILL IN THE 300'S MG/DL EVEN THOUGH HE HAS SWITCHED TO INJECTION THERAPY. HE STATED HE HAS TRIED TO CONTACT HIS DOCTOR AND HE WAS ADVISED TO CONTINUE TO DO SO. THE PT REQUESTED A REPLACEMENT DEVICE. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention INSULIN INFUSION SET| INSULIN