BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD DASH INSULIN MANAGEMENT SYSTEM

    MDR report key: 16512253 · Received March 9, 2023

    Report

    Report Number
    3004464228-2023-06589
    Event Type
    Injury
    Date Received
    March 9, 2023
    Date of Event
    March 4, 2023
    Report Date
    March 4, 2023
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385082000020
    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 ER VISIT 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT WENT TO THE EMERGENCY ROOM (ER) DUE TO HIGH BLOOD GLUCOSE (BG) LEVELS REACHING 366 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. THE PATIENT WAS VOMITING. AT THE HOSPITAL, THE PATIENT WAS PLACED ON INTRAVENOUS THERAPY OF FLUIDS. THE PATIENT WAS RELEASED A FEW HOURS LATER WHEN BG'S RETURNED TO NORMAL RANGE. THE PATIENT'S BLOOD GLUCOSE, CARBOHYDRATE, AND INSULIN HISTORY ARE AS FOLLOWS: DATE/ TIME (MILITARY) BG(MG/DL) : (B)(6), 2100, 116. 0026, 285. 0454 , 307. 1110 316. 1237 (CHANGED POD), 366. 1642, 315. 2137, 312.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716091 OMNIPOD DASH INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 18320 PD1U03222211 20385082000020

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Hospitalization