BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD 5 CONTROLLER

    MDR report key: 20901792 · Received December 11, 2024

    Report

    Report Number
    3004464228-2024-49710
    Event Type
    Injury
    Date Received
    December 11, 2024
    Date of Event
    November 21, 2024
    Report Date
    December 11, 2024
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    10385083000022
    PMA / PMN Number
    K203768
    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 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 THAT THE PATIENT HAD BEEN HOSPITALIZED WITH HYPERGLYCEMIA. THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 913 MG/DL. THE PATIENT REPORTED DUE TO ISSUES WITH THEIR PDM (PERSONAL DIABETES MANAGER) THEY HAVE BEEN OFF THE OMNIPOD SYSTEM. ACCORDING TO THE PATIENT THE CONTROLLER AND CHARGING CABLE WERE NOT WORKING AND THE REPLACEMENT WAS DELAYED IN SHIPPING (REPORTED IN ASSOCIATED FILES). PATIENT HAS BEEN ON AN ALTERNATE FORM OF INSULIN DELIVERY WHICH HAS NOT ADEQUATELY CONTROLLED HER BLOOD GLUCOSE LEVELS. SYMPTOMS REPORTED INCLUDE NAUSEA, VOMITING, HEADACHES, DIZZINESS, AND INSATIABLE THIRST. TREATMENT INFORMATION WAS NOT PROVIDED. THE PATIENT WAS STILL IN THE HOSPITAL AT THE TIME OF THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2573571 OMNIPOD 5 CONTROLLER ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-001827 10385083000022

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Hospitalization