BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIO

    MDR report key: 11811724 · Received May 12, 2021

    Report

    Report Number
    3003442380-2021-00002
    Event Type
    Injury
    Date Received
    May 12, 2021
    Date of Event
    March 18, 2021
    Report Date
    May 12, 2021
    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

    N/A.

    Description of Event or Problem · 1

    UNOMEDICAL REFERENCE: (B)(4). A DIABETIC IS TREATED WITH INSULIN VIA A MEDTRONIC INSULIN PUMP AND A MEDTRONIC MINIMED MIO BLUE MMT-945 INFUSION SET. THE INFUSION SET IS MANUFACTURED BY UNOMEDICAL A/S. ON (B)(6) 2021 THE PATIENT EXPERIENCE ELEVATED BLOOD GLUCOSE AT 1200 MG/DL FOLLOWED BY A FALL AND CONCUSSION, PATIENT CALLS EMS AND THEN EXPERIENCE COMA. PATIENT IS TAKEN TO ER WHERE HE IS HOSPITALISED AT GROVE CITY HOSPITAL AND WAS IN COMA FOR SIX DAYS. PATIENT CLAIMS THAT THE HYPERGLYCEMIA AND THE FALL IS CAUSED BY THE INFUSION SET WHICH UNKNOWINGLY DETACHED. AT THE MEDTRONIC HELPDESK THE SUGGESTED TROUBLESHOOTING REGARDING THE DETACHMENT IS DECLINED BY THE PATIENT. DURATION OF THE USE OF THE INFUSION SET IN QUESTION IS UNKNOWN TO THE PATIENT. LOT/BATCH NUMBER IS UNKNOWN. NO FURTHER DETAILS ARE AVAILABLE. CAUSALITY, IN PARTICULAR TO THE COMA, REMAINS SOMEWHAT UNCLEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711628 MIO INSULIN INFUSION SET FPA UNOMEDICAL A/S MMT-945 UNKNOWN 05705244007314

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization