BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD 5 AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 22950628 · Received September 3, 2025

    Report

    Report Number
    3004464228-2025-39305
    Event Type
    Injury
    Date Received
    September 3, 2025
    Date of Event
    August 1, 2025
    Report Date
    September 17, 2025
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    20385083000548
    PMA / PMN Number
    K231826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR IS A DUPLICATE OF 3004464228-2025-38834-00 SUBMITTED ON 29AUG25, THEREFORE THIS MDR IS CANCELLED.

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE AVAILABLE FOR INVESTIGATION BECAUSE IT WAS DISCARDED BY THE PATIENT. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED HOSPITALIZATION AND HYPERGLYCEMIA. 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. 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 [1] 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 [1] 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. 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 THAT THE PATIENT HAD BEEN HOSPITALIZED WITH HYPERGLYCEMIA ON (B)(6) 2025. THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 26 MMOL/L (468 MG/DL) WHILE WEARING THE POD BETWEEN 5 AND 24 HOURS. SYMPTOMS REPORTED INCLUDE FATIGUE, NAUSEA, THIRST, HEADACHE AND LACK OF APPETITE AND KETONES WERE MEASURED AT 4.3. THE PATIENT WAS TREATED WITH INSULIN PEN INJECTIONS, 20 UNITS IN THE MORNING AND THEN 40 IN THE EVENING. THE PATIENT WAS RELEASED AFTER 7 DAYS, (B)(6) 2025. THE POD WAS DISCARDED AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1734740 OMNIPOD 5 AUTOMATED INSULIN DELIVERY SYSTEM AUTOMATED INSULIN DELIVERY SYSTEM QFG INSULET CORPORATION PT-001446 PH1K12022431 20385083000548

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Female Hospitalization