BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSET II

    MDR report key: 24787974 · Received April 6, 2026

    Report

    Report Number
    3003442380-2026-88293
    Event Type
    Injury
    Date Received
    April 6, 2026
    Date of Event
    February 7, 2026
    Report Date
    March 9, 2026
    Manufacturer
    TANDEM
    Product Code
    FPA
    UDI-DI
    05705244018129
    PMA / PMN Number
    K032854
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL 3 OF 6. BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER: REPORTING SITE: 8021545, MANUFACTURING SITE: 3003442380.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED SIX BENT CANNULA ISSUES EVENT ON 07 FEB 2026, 09 FEB 2026, 21 FEB 2026, 03 MAR 2026. THE SITE OF INSERTION WAS ABDOMEN, AND THE INFUSION SET WAS IN USE FOR FEW HOURS. DUE TO THE EVENT, PATIENT SUBSEQUENTLY WENT EMERGENCY ROOM DUE TO HIGH BLOOD GLUCOSE LEVEL MEASURING 30 MMOL/L AND WAS TREATED WITH CORRECTION INJECTION VIA MULTIPLE DAILY INJECTIONS AND INTRAVENOUS FLUIDS OF SALINE AND INSULIN. THE PATIENT REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. THE PATIENT RELEASED FROM THE EMERGENCY ROOM ON (B)(6) 2026.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852944 INSET II SET, ADMINISTRATION, INTRAVASCULAR FPA TANDEM 1002817 6008815 05705244018129

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Female