BEUDAMED
    FDA Adverse Event Injury Summary report: N

    H-TRONPLUS

    MDR report key: 1012658 · Received March 11, 2008

    Report

    Report Number
    2183996-2008-00317
    Event Type
    Injury
    Date Received
    March 11, 2008
    Date of Event
    February 23, 2008
    Report Date
    February 23, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    LZG
    PMA / PMN Number
    K023471
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTED AN ELEVATED BLOOD GLUCOSE READING OF 500 MG/DL. SHE STATED SHE RECEIVED AN 04 MESSAGE ON HER INSULIN INFUSION DEVICE. SHE SAID THE PISTON ROD ON THE DEVICE IS OVER A YR OLD AND THE ADAPTER HAS BEEN IN PLACE FOR A WHILE. THE PT WAS ADVISED THE PISTON ROD MUST BE CHANGED EVERY YR AND THE ADAPTER EVERY 6 MONTHS. THE PT WAS INSTRUCTED TO CHANGE THE DEVICE BATTERIES AND REMOVE ALL DEVICE ACCESSORIES AND RUN A DRY PRIME WHICH WENT THROUGH WITHOUT ERROR. THE PT WAS ADVISED TO SWITCH TO HER BACKUP DEVICE AND WAS SENT NEW BATTERIES. ON FOLLOW UP THE SAME DAY, THE PT STATED HER BLOOD GLUCOSE READINGS ARE STILL ELEVATED AND HER PRIMARY DEVICE HAS NOW GIVEN AN 09 (END OF LIFE) ALARM. ON FURTHER FOLLOW UP, THE PT STATED HER READINGS ARE STILL ELEVATED AND HER DR HAS TAKEN HER OFF PUMP THERAPY. 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 H-TRONPLUS NA

    Patients

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