BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD DASH, PODS 10-PACK

    MDR report key: 24590689 · Received March 13, 2026

    Report

    Report Number
    3014585508-2026-13662
    Event Type
    Injury
    Date Received
    March 13, 2026
    Date of Event
    February 11, 2026
    Report Date
    March 13, 2026
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385082000112
    PMA / PMN Number
    K211575
    Adverse Event
    Yes
    Product Problem
    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. LOT RELEASE RECORDS WERE REVIEWED, AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED HOSPITALIZATION AND DIABETIC KETOACIDOSIS.

    Description of Event or Problem · 0

    THE PARENT REPORTED THAT THE PATIENT WAS WEARING THE POD ON THE LEG FOR AN UNKNOWN DURATION OF USE PRIOR TO THE ONSET OF SYMPTOMS. ACCORDING TO THE PARENT, THE PATIENT¿S GLUCOSE LEVELS RANGED BETWEEN 12 MMOL/L (216 MG/DL) AND 13 MMOL/L (234 MG/DL), AND THE PATIENT WAS EXPERIENCING VOMITING AND STOMACH PAIN. IN RESPONSE TO THESE ELEVATED GLUCOSE LEVELS, THE PARENT ADMINISTERED INSULIN USING A PEN. THE PARENT CONFIRMED THAT THE POD ADHESIVE REMAINED SECURE THROUGHOUT WEAR AND THAT THE PINK SLIDE HAD MOVED FORWARD AS EXPECTED. DUE TO THE PRESENCE OF KETONES AND CONTINUED VOMITING, THE PARENT CHANGED THE POD BEFORE SEEKING MEDICAL ATTENTION. THE PARENT BROUGHT THE PATIENT TO THE HOSPITAL ON (B)(6) 2026, WHERE MEDICAL STAFF REVIEWED THE CONTROLLER HISTORY AND INFORMED THE PARENT WITH THE BELIEF THAT THE EVENT APPEARED TO BE A POD FAILURE; HOWEVER, NO FURTHER DETAILS WERE PROVIDED. THE PATIENT WAS DIAGNOSED WITH DIABETIC KETOACIDOSIS AND RECEIVED INTRAVENOUS INSULIN, AS WELL AS MEDICATION TO ADDRESS VOMITING (SPECIFIC MEDICATION NAMES WERE NOT PROVIDED). THE PATIENT REMAINED UNDER MEDICAL CARE FOR 24 HOURS AND WAS DISCHARGED ON (B)(6) 2026.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648803 OMNIPOD DASH, PODS 10-PACK PUMP, INFUSION, INSULIN LZG INSULET CORPORATION PT-000029 PD1U09122523 20385082000112

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Female Required Intervention