BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD 5 AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 24372957 · Received February 17, 2026

    Report

    Report Number
    3014585508-2026-08275
    Event Type
    Injury
    Date Received
    February 17, 2026
    Date of Event
    January 31, 2026
    Report Date
    February 17, 2026
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    PMA / PMN Number
    K203768
    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 HOSPITALIZATION AND DIABETIC KETOACIDOSIS. 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. [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. LOCKED DOWN SMARTPHONE: LOCKDOWN. OMNIPOD SOFTWARE APP VERSION: 3.1.6. OPERATING SYSTEM: N5004L-AM-Q-MV01602-06-01.06. HARDWARE: N5004L. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD BEEN HOSPITALIZED AT CREDIT VALLEY HOSPITAL WITH DIABETIC KETOACIDOSIS (DKA) ON (B)(6) 2026. THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 43.2 MMOL/L (778 MG/DL) WHILE WEARING THE POD BETWEEN 5 AND 24 HOURS. REPORTED SYMPTOMS INCLUDED CONFUSION, BLURRY VISION, IMPAIRED SPEECH, EXCESSIVE THIRST, INCREASED URINATION, GENERALIZED WEAKNESS, AND NAUSEA. THE PATIENT WAS TREATED WITH INTRAVENOUS INSULIN (HUMALOG AND BASAGLAR). THE PATIENT WAS DISCHARGED ON (B)(6) 2026.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432280 OMNIPOD 5 AUTOMATED INSULIN DELIVERY SYSTEM ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-001925 PH1U06132511

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Hospitalization