BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIO

    MDR report key: 8792538 · Received July 16, 2019

    Report

    Report Number
    3003442380-2019-00005
    Event Type
    Injury
    Date Received
    July 16, 2019
    Date of Event
    May 21, 2019
    Report Date
    July 16, 2019
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244007314
    PMA / PMN Number
    K160648
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFUSION SET LOT 5251213 REFERENCE SAMPLES HAVE BEEN INVESTIGATED TO BE FULLY WITHIN SPECIFICATIONS. BATCH REVIEW HAS BEEN PERFORMED AND ARE WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    UNOMEDICAL REFERENCE: (B)(4). A MALE DIABETIC IS TREATED WITH INSULIN VIA A MEDTRONIC INSULIN PUMP AND A MEDTRONIC MIO PARADIGM MMT-941 INFUSION SET. HE ALSO USES A CGM SENSOR/TRANSMITTER. NOTE: HE IS NEW TO PUMP AND TO CGMS THERAPY. ON (B)(6) 2019 HE EXPERIENCE ELEVATED BLOOD GLUCOSE AT 400 MG/DL FOLLOWED BY SEIZURE. EMS TAKES PATIENT TO A HOSPITAL ((B)(6) HOSPITAL) WHERE HE IS IN COMA FOR THREE DAYS AND REMAIN HOSPITALIZED FOR TWO WEEKS. THERE ARE NO DATA INDICATING ANY PUMP FAILURE, INFUSION SET FAILURE OR SENSOR/TRANSMITTER FAILURE. IN EARLY JUNE IT IS STATED, THAT PATIENT 'IS STILL WORKING WITH HIS PHYSICIAN TO BE MORE AGGRESSIVE WITH HIS PUMP SETTINGS'.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586643 MIO INSULIN INFUSION SET FPA UNOMEDICAL A/S MMT-941 5251213 05705244007314

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L