BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD 5 PODS

    MDR report key: 25079259 · Received May 5, 2026

    Report

    Report Number
    3014585508-2026-25681
    Event Type
    Injury
    Date Received
    May 5, 2026
    Date of Event
    April 1, 2026
    Report Date
    May 5, 2026
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    20385083000579
    PMA / PMN Number
    K231826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 EMERGENCY ROOM VISIT AND HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED, AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. LOCKED DOWN SMARTPHONE: PHONE_CONTROL_IOS: OMNIPOD SOFTWARE APP VERSION: 2.1.0, OPERATING SYSTEM: 26.3, HARDWARE: IPHONE15.4, CGM SENSOR TYPE: G7. 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. HIGH BLOOD GLUCOSE IS A COMMON SYMPTOM FOR PEOPLE WITH DIABETES (GLUCOSE MONITORING DATA FROM PEOPLE WITH DIABETES INDICATE THAT ON AVERAGE, THEY CAN EXPERIENCE BLOOD GLUCOSE LEVELS ABOVE 250 MG/DL FOR 14-25% OF THE TIME[1][2][3]), AND IT WOULD BE CHALLENGING TO SPECULATE ON A CAUSE FOR THE COMPLAINTS WITHOUT RECEIVING THE DEVICES BACK FOR AN ENGINEERING INVESTIGATION. [1] BECK RW, BERGENSTAL RM, CHENG P, KOLLMAN C, CARLSON AL, JOHNSON ML, RODBARD D. THE RELATIONSHIPS BETWEEN TIME IN RANGE, HYPERGLYCEMIA METRICS, AND HBA1C. J DIABETES SCI TECHNOL 2019; 13:614-626. [2] WELSH JB, DERDZINSKI M, PARKER AS, PUHR S, JIMENEZ A, WALKER T. REAL-TIME SHARING AND FOLLOWING OF CONTINUOUS GLUCOSE MONITORING DATA IN YOUTH. DIABETES THER 2019; 10:751-755. [3] PUHR S, DERDZINSKI M, WELSH JB, PARKER AS, WALKER T, PRICE DA. REAL-WORLD HYPOGLYCEMIA AVOIDANCE WITH A CONTINUOUS GLUCOSE MONITORING SYSTEM'S PREDICTIVE LOW GLUCOSE ALERT. DIABETES TECHNOL THER 2019; 21:155-158.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD VISITED THE EMERGENCY ROOM (ER) WITH HYPERGLYCEMIA ON (B)(6) 2026. THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED AN ESTIMATED 400 MG/DL WHILE WEARING THE POD LONGER THAN 48 HOURS ON THE HIP/BUTTOCKS. THE PATIENT BEGAN FEELING UNWELL AND REMOVED THE POD, REPLACING IT WITH A NEW POD, AND DROVE TO THE ER. SYMPTOMS REPORTED INCLUDED NAUSEA AND FEELING TIRED. THE PATIENT WAS TREATED WITH INTRAVENOUS FLUIDS. THE PATIENT LEFT THE ER THE SAME DAY AND A NEW POD WAS APPLIED. WHILST REVIEWING THE PATIENT'S DEVICE NOTIFICATIONS, IT WAS FOUND THAT THERE WERE MISSING SENSOR VALUES. THE PATIENT DID NOT ADDRESS THIS AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417774 OMNIPOD 5 PODS OMNIPOD 5 PODS QFG INSULET CORPORATION PT-001662 PH1K07242521 20385083000579

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Required Intervention