BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD DASH INSULIN MANAGEMENT SYSTEM

    MDR report key: 24757806 · Received April 1, 2026

    Report

    Report Number
    3014585508-2026-17427
    Event Type
    Injury
    Date Received
    April 1, 2026
    Date of Event
    March 25, 2026
    Report Date
    April 1, 2026
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385082000020
    PMA / PMN Number
    K211575
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED HOSPITAL VISIT AND HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED, AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 0

    THE PATIENT¿S FATHER REPORTED THAT ON THE EVENING OF (B)(6) THE PATIENT¿S BLOOD GLUCOSE (BG) ROSE RAPIDLY DESPITE NO FOOD INTAKE, TRIGGERED ALARMS AT 250 MG/DL (13.9 MMOL/L), AND CONTINUED TO CLIMB DESPITE THREE CORRECTION DOSES. THE HOSPITAL WAS CONTACTED BY PHONE, AND THE MEDICAL STAFF ADVISED REPLACING THE POD. AFTER REPLACEMENT, BG LEVELS STILL ROSE AND REACHED AS HIGH AS 480 MG/DL (26.7 MMOL/L) THAT NIGHT, LEADING TO A VISIT TO THE HOSPITAL IN VIENNA¿S 10TH DISTRICT. IT WAS REPORTED THAT BG LEVELS ROSE TO 530 MG/DL (29.4 MMOL/L) WHILE IN THE HOSPITAL. THE FATHER STATED THAT DURING HOSPITAL CARE OVER APPROXIMATELY TWO TO THREE HOURS, MEDICAL STAFF ASSISTED AND GLUCOSE DECREASED. THE POD WAS REMOVED FROM THEIR ARM, AND THE PATIENT WAS TREATED WITH INSULIN INJECTIONS UNDER MEDICAL SUPERVISION. THE BG LEVELS RETURNED TO NORMAL AND ONCE STABILIZED, THE PATIENT WAS ABLE TO RETURN HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819818 OMNIPOD DASH INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 18320 PD1K08152541 20385082000020

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Female Required Intervention