BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED QUICK-SET

    MDR report key: 19737771 · Received July 14, 2024

    Report

    Report Number
    3003442380-2024-14312
    Event Type
    Injury
    Date Received
    July 14, 2024
    Date of Event
    June 4, 2024
    Report Date
    December 12, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244017450
    PMA / PMN Number
    K160648
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 1912053 - MDR 3003442380-2024-14312 - DEVICE 2 OF 4 E1: PATIENT CITY: (B)(6). PATIENT COUNTRY: UNITED STATES.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES IT WAS REPORTED THAT PATIENT FACED 4 INFUSION SET CANNULA BENT EVENTS ON 04-JUN-2024, 05-JUN-2024 AND 07-JUN-2024. THE BLOOD GLUOSE LEVEL WAS 400 MG/DL ON 04-JUN-2024. THE PATIENT WAS HOSPITALIZED ON (B)(6) 2024 BECAUSE BLOOD GLUCOSE WAS 800 MG/DL. UNOMEDICAL DO NOT SEE BENT AS BEING RELATED TO HUMAN FACTORS, BUT RATHER AS A TRAINING ISSUE INCLUDING CORRECT CHOICES OF INSERTION SITES AND INFUSION SETS AND CANNULA LENGTH. FURTHERMORE, THE SOFT CANNULA IS A FLEXIBLE MATERIAL THAT DURING USE AND UPON REMOVAL CAN BEND SLIGHTLY. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1392172 MINIMED QUICK-SET UNO QUICK-SET 60/6 SC1 MECA FPA UNOMEDICAL A/S MMT-399A 6001316 05705244017450

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R