BEUDAMED
    FDA Adverse Event Injury Summary report: N

    D-TRONPLUS

    MDR report key: 1100817 · Received August 6, 2008

    Report

    Report Number
    2183996-2008-01172
    Event Type
    Injury
    Date Received
    August 6, 2008
    Date of Event
    July 14, 2008
    Report Date
    August 5, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    LZG
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS HOSPITALIZED IN 208 DUE TO KETOACIDOSIS AND COMA. THE MEDICAL STAFF REPORTED THAT THE PATIENT HAD BEEN UNCONSCIOUS FOR 4 DAYS WITH RETROGRADE AMNESIA. THE PATIENT WAS CONNECTED TO THE INFUSION DEVICE UPON ADMISSION TO THE HOSPITAL AND IT WAS REMOVED BY THE MEDICAL STAFF. NO FURTHER INFORMATION IS AVAILABLE. 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 Hospitalization| R INSULIN INFUSION SET| INSULIN