BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD 5 POD

    MDR report key: 16919319 · Received May 12, 2023

    Report

    Report Number
    3004464228-2023-12325
    Event Type
    Injury
    Date Received
    May 12, 2023
    Date of Event
    May 3, 2023
    Report Date
    May 7, 2023
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    10385083000114
    PMA / PMN Number
    K203768
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    D4: CATALOG # CHANGED FROM PDM-H001-G-XX TO POD-BLE-H1-520; D4: UNIQUE IDENTIFIER (UDI) # CHANGED FROM(B)(4) TO (B)(4) D4 MODEL # CHANGED FROM PT-000409 TO PT-000435; H4: DEVICE MFG DATE: CHANGED FROM 9/9/2022 TO NONE.

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED HOSPITALIZATION AND HYPERGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD BEEN HOSPITALIZED WITH HYPERGLYCEMIA. THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED ABOVE 800 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS ON THE ABDOMEN. THE PATIENT WAS PLACED ON AN INTRAVENOUS THERAPY OF FLUIDS AND INSULIN. THE PATIENT WAS CURRENTLY STILL IN THE HOSPITAL AT THE TIME OF THE CALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1167672 OMNIPOD 5 POD ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-000435 10385083000114

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Hospitalization