BEUDAMED
    FDA Adverse Event Injury Summary report: N

    H-TRONPLUS

    MDR report key: 1192454 · Received October 7, 2008

    Report

    Report Number
    2183996-2008-01534
    Event Type
    Injury
    Date Received
    October 7, 2008
    Date of Event
    September 21, 2008
    Report Date
    September 23, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    LZG
    PMA / PMN Number
    K023471
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PT REPORTED THAT HER BLOOD GLUCOSE HAS BEEN AS ELEVATED 600 MG/DL THIS WEEK. TYPICALLY HER BLOOD GLUCOSE "AVERAGES OUT TO ABOUT 250 MG/DL". SHE STATED THAT SHE HAS GASTROPARESIS AND IS GOING THROUGH MENOPAUSE. DUE TO THE GASTROPARESIS SHE HAS A PORT IN HER STOMACH TO RECEIVE NUTRITIONAL SUPPLEMENTS. SHE STATED THAT SHE IS ALSO CURRENTLY TAKING SLEEPING PILLS. THE PT WAS CONFIDENT THAT THE TIME AND BASAL RATES WERE ACCURATELY PROGRAMMED ON THE INFUSION DEVICE. SHE CHANGES HER INFUSION SITE EVERY 3-4 DAYS. SHE WAS ADVISED TO CHANGE THE INFUSION SITE EVERY 3 DAYS. TROUBLESHOOTING DID NOT REVEAL ANY PRODUCT ISSUES. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REQUESTED TO BE RETURNED FOR EVAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R INSULIN INFUSION SET| INSULIN