BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD 5 AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 22059245 · Received May 21, 2025

    Report

    Report Number
    3004464228-2025-22054
    Event Type
    Injury
    Date Received
    May 21, 2025
    Date of Event
    May 13, 2025
    Report Date
    May 21, 2025
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    10385083000138
    PMA / PMN Number
    K203768
    Adverse Event
    Yes
    Product Problem
    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. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. 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. CLOUD - LOCKED DOWN/SMARTPHONE. DATA NOT AVAILABLE. CLOUD - OMNIPOD 5 SOFTWARE APP VERSION. DATA NOT AVAILABLE. CLOUD - SMARTPHONE OPERATING SYSTEM. DATA NOT AVAILABLE. CLOUD - SMARTPHONE HARDWARE. DATA NOT AVAILABLE. CLOUD - 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 MOTHER REPORTED THE POD FELL OFF THE INSERTION SITE (ABDOMEN) AFTER 2 HOURS OF WEAR. PATIENT DID NOT NOTICE THE POD FELL OFF AND THEIR BLOOD GLUCOSE LEVELS ROSE TO 425 MG/DL. THE PATIENT'S TEACHER DROVE HIM TO THE HOSPITAL BECAUSE THE PATIENT DID NOT KNOW HOW MANY UNITS OF NOVORAPID BACKUP INSULIN TO ADMINISTER. PATIENT WAS ADMITTED TO CHILDREN'S HOSPITAL DRITTER ORDEN PASSAU, LOCATED AT BISCHOF-ALTMANN-STRASSE 9, 94032 PASSAU, GERMANY FROM (B)(6) 2025 FOR A METABOLIC ADJUSTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77586 OMNIPOD 5 AUTOMATED INSULIN DELIVERY SYSTEM ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-000438 PH1K03082431 10385083000138

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Female Hospitalization