BEUDAMED
    FDA Adverse Event Death Summary report: N

    MIO

    MDR report key: 7662262 · Received July 4, 2018

    Report

    Report Number
    3003442380-2018-00028
    Event Type
    Death
    Date Received
    July 4, 2018
    Date of Event
    May 24, 2018
    Report Date
    July 4, 2018
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244007338
    PMA / PMN Number
    K160648
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE STATED MANY SET CHANGES DURING 3-4 DAYS MAY INDICATE PATIENT HAVING PROBLEMS WITH EITHER THE INFUSION SETS OR HAVING PUMP PROBLEMS (I.E. THE CONSTANT PUMP ALARMS RESULTED IN THE PATIENT HAVING REMOVED HIS PUMP). DATA DOES NOT ALLOW MAKING PROPER ASSESSMENT OF CAUSAL RELATIONSHIP BETWEEN PUMP/DKA AND/OR INFUSION SET/DKA.

    Description of Event or Problem · 1

    (B)(4). (B)(6). A WIDOW REPORTS TO MEDTRONIC HELPLINE THAT HER HUSBAND PASSED AWAY ON (B)(6) 2018 AFTER BEING ADMITTED TO HOSPITAL ON (B)(6) 2018 WITH DIABETIC KETOACIDOSIS (DKA). REPORTEDLY, PHYSICIANS STATE CAUSE OF DEATH AS SEVERE DKA. IT IS REPORTED THAT BLOOD GLUCOSE (BG) HAD BEEN HIGH FOR THE PREVIOUS COUPLE OF DAYS. A ROOMMATE INFORMED THAT THE PUMP WAS CONSTANTLY ALARMING SO THE PATIENT THEREFORE REMOVED THE PUMP. IT IS REPORTED THAT THE PATIENT FOR 3-4 DAYS PERFORMED MULTIPLE DAILY (SITE/SET) CHANGES. NO FURTHER INFORMATION IS AVAILABLE OR EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504383 MIO INSULIN PUMP INFUSION SET FPA UNOMEDICAL A/S MMT-941600 UNKNOWN 05705244007338

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H