BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD DASH INSULIN MANAGEMENT SYSTEM

    MDR report key: 24954115 · Received April 22, 2026

    Report

    Report Number
    3014585508-2026-22134
    Event Type
    Injury
    Date Received
    April 22, 2026
    Date of Event
    March 27, 2026
    Report Date
    April 23, 2026
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385082000051
    PMA / PMN Number
    K211575
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN RETURNED HOWEVER OUR INVESTIGATION IS STILL ONGOING. WHEN THE INVESTIGATION IS CONCLUDED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE RESULTS. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED HOSPITALIZATION AND DIABETIC KETOACIDOSIS. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.

    Additional Manufacturer Narrative · 0

    CORRECTION: FIELD H6: CODE A26 REMOVED AND CODE A040609 ADDED. CODE G04019 ADDED. EVALUATION: THE POD GENERATED AN 0X1C EXPIRATION ALARM. THE DEVICE WAS CONFIRMED TO HAVE RUN FOR 80 HOURS. INSPECTION OF THE SOFT CANNULA DID NOT FIND IT TO BE BENT, KINKED, OR OTHERWISE DAMAGED. NO DEFECTS WERE OBSERVED ON THE ADHESIVE PAD OR ITS WELDS THAT WOULD CONTRIBUTE TO THE REPORTED ADHESIVE FAILURE, THE CAUSE OF WHICH COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS TAKEN TO HOSPITAL IN AN AMBULANCE AND ADMITTED ON (B)(6) 2026 WITH DIABETIC KETOACIDOSIS AND AN UNKNOWN BACTERIAL INFECTION. THE PATIENT¿S BLOOD GLUCOSE LEVELS ROSE ABOVE 300 MG/DL WHILE WEARING THE POD BETWEEN 36 AND 48 HOURS. THE PATIENT REPORTED THAT THE ADHESIVE ON THE POD HAD COME SLIGHTLY LOOSE FROM THE INFUSION SITE (LEG) AND THAT WHEN THE POD WAS REMOVED THE CANNULA WAS SLIGHTLY BENT. REPORTED SYMPTOMS INCLUDE DIZZINESS, INABILITY TO WALK AND NAUSEA WITH RETCHING. THE PATIENT WAS TREATED WITH INTRAVENOUS INSULIN, INTRAVENOUS FLUIDS, UNSPECIFIED ANTIBIOTICS AND ELECTROLYTES. THE PATIENT WAS DISCHARGED ON (B)(6) 2026, TWO OF THE DAYS THE PATIENT WAS HOSPITALISED WERE SPENT IN THE INTENSIVE CARE UNIT (ICU (EXACT DATES OF ICU STAY NOT PROVIDED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267513 OMNIPOD DASH INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 18325 PD1U10282511 20385082000051

    Patients

    Seq Age Sex Outcome Treatment
    1