BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD 5 AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 22011552 · Received May 13, 2025

    Report

    Report Number
    3004464228-2025-20695
    Event Type
    Injury
    Date Received
    May 13, 2025
    Date of Event
    April 26, 2025
    Report Date
    May 13, 2025
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    10385083000190
    PMA / PMN Number
    K203768
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    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 EVENT. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED. LOCKED DOWN SMARTPHONE: DATA NOT AVAILABLE OMNIPOD SOFTWARE APP VERSION: DATA NOT AVAILABLE SMARTPHONE OPERATING SYSTEM: DATA NOT AVAILABLE SMARTPHONE HARDWARE: DATA NOT AVAILABLE CGM SENSOR TYPE: DATA NOT AVAILABLE *PLEASE NOTE, THAT SECTION D IS CAPTURING THE DEVICE IDENTIFIERS AS REPORTED BY THE COMPLAINANT.  THIS MAY NOT ALIGN TO THE DEVICE CONFIGURATION REPORTED IN H11, AS THIS DATA IS PULLED FROM OUR CLOUD BASED ON THE REPORTED DATE OF EVENT.

    Description of Event or Problem · 0

    THE PATIENT'S LEGAL GUARDIAN (LG) REPORTED THAT OVER THE LAST 3 WEEKS THEY HAVE HAD TO SEEK MEDICAL ATTENTION DUE TO EITHER HIGH OR LOW BLOOD GLUCOSE (BG) LEVELS AND DIABETIC KETOACIDOSIS (DKA). THE PATIENT'S GUARDIAN DID NOT PROVIDE SPECIFIC BG LEVELS, BUT DID SAY THEY WERE "DANGEROUSLY HIGH," AND KETONES MEASURED 1.6 MG/DL SYMPTOMS REPORTED INCLUDE HYPERGLYCEMIA AND NUMB LEGS. FOR ALL 3 EVENTS AN AMBULANCE WAS CALLED FROM UNIKLINIK KOELN AND NEZ KOELN AND TREATED THE PATIENT WITH INSULIN INJECTIONS FOR HIGH BG'S AND SUGAR FOR LOW BG'S. THE LG REQUESTED A REPLACEMENT DEVICE AND INSULET WILL PROVIDE ADDITIONAL TRAINING WITH THE DEVICE. THIS IS INCIDENT 1 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2356874 OMNIPOD 5 AUTOMATED INSULIN DELIVERY SYSTEM ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-001193 10385083000190

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Female