BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D-TRONPLUS

    MDR report key: 1163442 · Received September 10, 2008

    Report

    Report Number
    2183996-2008-01382
    Event Type
    Malfunction
    Date Received
    September 10, 2008
    Date of Event
    August 21, 2008
    Report Date
    August 21, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    LZG
    PMA / PMN Number
    K043000
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PT REPORTED HIS INSULIN INFUSION DEVICE DISPLAYED AN E5 (END OF LIFE) MESSAGE WITHOUT FIRST GIVING THE A5 MESSAGE ALERTING HIM TO THE END OF LIFE. THE PT DID NOT REPORT BLOOD GLUCOSE CONCERNS RELATED TO THIS ISSUE. THE PT DID NOT REQUIRE 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 NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR INSULIN| INSULIN INFUSION SET