BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD DASH INSULIN MANAGEMENT SYSTEM

    MDR report key: 22716892 · Received August 5, 2025

    Report

    Report Number
    3004464228-2025-34804
    Event Type
    Injury
    Date Received
    August 5, 2025
    Date of Event
    July 26, 2025
    Report Date
    August 5, 2025
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    10385082000139
    PMA / PMN Number
    K211575
    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 HOSPITALIZATION AND DIABETIC KETOACIDOSIS. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED. "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".

    Description of Event or Problem · 0

    REPORT WAS RECEIVED FROM A NURSE ON (B)(6) 2025 ABOUT A PATIENT THAT HAD BEEN HOSPITALIZED AT KLINIKUM HERFORD, SCHWARZENMOORSTRASSE 70, 32049 HERFORD (MS. DR. HOANG) WITH DIABETIC KETOACIDOSIS (DKA) ON (B)(6) 2025. ON (B)(6) 2026 THE PDM STATED AN ERROR ¿PDM WEAK BATTERY, COMMUNICATION ERROR.¿ THE PATIENT NEEDED TO CHARGE THE PDM EVERY 2-4 HOURS. ON (B)(6) 2025 THE PATIENT WAS ADMITTED TO INTENSIVE CARE UNIT (ICU) WITH SYMPTOMS OF NAUSEA, VOMITING, UNRESPONSIVENESS, PH OF 7.0, KETONES +4, AND BLOOD GLUCOSE LEVELS REACHED 1200 MG/DL. SYMPTOMS REPORTED INCLUDE HYPERGLYCEMIA AND EXCESSIVE PAIN. THE PATIENT WAS DIAGNOSED WITH KETOACIDOSIS. IT WAS NOT REPORTED IF THE PATIENT WAS WEARING A POD AT THE TIME OF SEEKING MEDICAL ATTENTION. THE PATIENT WAS TREATED WITH INSULIN INFUSION AND JONOSTERIL. THE PATIENT WAS STILL IN THE ICU AT THE TIME OF THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2651610 OMNIPOD DASH INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION PT-000010 10385082000139

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Male Hospitalization