BEUDAMED
    FDA Adverse Event Death Summary report: N

    DISETRONIC INFUSION SET

    MDR report key: 145568 · Received January 22, 1998

    Report

    Report Number
    8021545-1998-00001
    Event Type
    Death
    Date Received
    January 22, 1998
    Date of Event
    December 14, 1997
    Report Date
    January 5, 1998
    Manufacturer
    MAERSK MEDICAL A/S
    Product Code
    FOZ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISETRONIC INFUSION SET SUBCUTANEOUS INSULIN INFUSION SET FOZ MAERSK MEDICAL A/S NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Death INSULIN: H-TRON V100 INSULIN INFUSION PUMP