BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC MINIMED

    MDR report key: 19700463 · Received July 9, 2024

    Report

    Report Number
    8021545-2024-01851
    Event Type
    Malfunction
    Date Received
    July 9, 2024
    Date of Event
    June 6, 2024
    Report Date
    July 9, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244022928
    PMA / PMN Number
    K210544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    E1: (B)(6).

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE CANADA. ON (B)(6) 2024, IT WAS REPORTED BY THE PATIENT THAT TUBE WAS BENT IN THE BEGINNING. PATEINT REPLACED HIGH READING OVER 200 - DELIVERED BOLUS. THE BLOOD GLUCOSE LEVEL WAS REPORTED HIGH DURING THE EVENT. PATEINT USED INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BG EVENT. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1498937 MEDTRONIC MINIMED UNO EWIS BLUE 60/6 HCAP 1-PK INT FPA UNOMEDICAL A/S MMT-431AH UNKNOWN 05705244022928

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose