BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC EXTENDED

    MDR report key: 19341154 · Received May 17, 2024

    Report

    Report Number
    3003442380-2024-02151
    Event Type
    Malfunction
    Date Received
    May 17, 2024
    Report Date
    May 17, 2024
    Product Code
    FPA
    UDI-DI
    05705244023079
    PMA / PMN Number
    K210544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MDR 3003442380-2024-02151- DEVICE 1 OF 3.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON (B)(6) 2024, IT WAS REPORTED THAT PATIENT FACED ADHESIVE ISSUE WITH THREE INFUSION SETS. INFUSION SET FELL OFF DURING USE. DURATION OF USE WAS 2 DAYS. THE BLOOD GLUCOSE LEVEL WAS 160-240 MG/DL. CUSTOMER REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744290 MEDTRONIC EXTENDED UNO EWIS BLUE 80/9 HCAP 1-PK INT FPA UNKNOWN 05705244023079

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown