BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD 5 AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 22553822 · Received July 21, 2025

    Report

    Report Number
    3004464228-2025-32285
    Event Type
    Injury
    Date Received
    July 21, 2025
    Date of Event
    June 10, 2025
    Report Date
    July 21, 2025
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    10385083000138
    PMA / PMN Number
    K203768
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED DIABETIC KETOACIDOSIS. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED. LOCKED DOWN SMARTPHONE: LOCKDOWN, OMNIPOD SOFTWARE APP VERSION: 3.1.2-P001, OPERATING SYSTEM: N5004L-AM-Q-MV01602-06-01.06, HARDWARE: N5004L, CGM SENSOR TYPE: G6. *PLEASE NOTE, THE DEVICE IDENTIFIERS ARE CAPTURED AS REPORTED BY THE COMPLAINANT AND MAY NOT ALIGN WITH THE DEVICE CONFIGURATION REPORTED IN THIS SECTION AS THIS DATA IS PULLED FROM OUR CLOUD BASED ON THE REPORTED DATE OF EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE (BG) LEVELS READ ¿HIGH¿ (> 27.8 MMOL/L) (> 500 MG/DL) WHILE WEARING THE POD ON THE ABDOMEN FOR BETWEEN 37 AND 48 HOURS. PATIENT DELIVERED MULTIPLE BOLUSES WITH NO EFFECT. SYMPTOMS REPORTED INCLUDE NAUSEA, ABDOMINAL PAIN, APATHETIC, HEADACHE AND WEAKNESS. PATIENT REMOVED AND APPLIED A NEW POD. UPON POD REMOVAL, PATIENT NOTICED THE POD HAD BEEN LEAKING. PATIENT VISITED THE DOCTOR'S OFFICE LOCATED AT MVZ ERFURT, MELCHENDORFER STRASSE 1, 99096 ERFURT, GERMANY THE FOLLOWING MORNING. THE DOCTOR AND DIABETES NURSE THOMAS FELBEL MEASURED KETONES AND BG LEVELS. A BG METER AND KETONE TEST STRIPS WERE PRESCRIBED. PATIENT WAS DIAGNOSED WITH DIABETIC KETOACIDOSIS. NO INSULIN INJECTION OR TREATMENT WAS REQUIRED AT THE DOCTOR'S OFFICE. PATIENT WAS RELEASED HOME AFTER 30 MINUTES. THE POD WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2752152 OMNIPOD 5 AUTOMATED INSULIN DELIVERY SYSTEM ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-000438 10385083000138

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female