BEUDAMED
    FDA Adverse Event Death Summary report: N

    DISETRONIC H-TRON V 100

    MDR report key: 147526 · Received February 6, 1998

    Report

    Report Number
    2183996-1998-00002
    Event Type
    Death
    Date Received
    February 6, 1998
    Date of Event
    December 14, 1997
    Report Date
    January 5, 1998
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS AG
    Product Code
    LZG
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A DIABETIC, UNDER INSULIN PUMP TREATMENT, IN GERMANY (BERLIN) HAD DIED OF DIABETIC KETOACIDOSIS (DKA).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISETRONIC H-TRON V 100 INSULIN PUMP LZG DISETRONIC MEDICAL SYSTEMS AG DISETRONIC H-TRON V100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Death DISETRONIC INFUSION SET (MFG BY MAERSK MEDICAL,| DENMARK).| INSULIN