BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD 5 AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 21812274 · Received April 10, 2025

    Report

    Report Number
    3004464228-2025-15661
    Event Type
    Injury
    Date Received
    April 10, 2025
    Date of Event
    April 8, 2025
    Report Date
    April 10, 2025
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    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 AVAILABLE FOR INVESTIGATION BECAUSE IT WAS DISCARDED BY THE PATIENT. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO CUSTOMER'S INFUSION SITE INFECTION. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED. 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 REPORTED WHEN DELIVERING A BOLUS, THE SITE WAS EXTREMELY PAINFUL. THE POD WAS REMOVED AFTER HAVING BEEN WORN FOR BETWEEN 5 AND 24 HOURS DUE TO THE PAIN AND NOTICED AN ABSCESS HAD FORMED WITH PURULENT DISCHARGE COMING OUT OF IT. THE PATIENT WENT TO URGENT CARE ON (B)(6) 2025 AND WAS ADVISED TO WAIT TO SEE IF THE ABSCESS WOULD HEAL ON IT'S OWN. THE PATIENT RETURNED TO URGENT CARE THE FOLLOWING DAY AND WAS PRESCRIBED CLARITHROMYCIN TABLETS 250 MG (TAKE 4 TIMES A DAY FOR 2 DAYS) FOR TREATMENT. THE SITE WAS NOT HEALING AND THE PATIENT RETURNED TO URGENT CARE ON (B)(6) 2025 AND WAS PRESCRIBED CLARITHROMYCIN TABLETS 500 MG (TAKE 4 TIMES A DAY FOR 5 DAYS) TO CLEAR UP THE INFECTION. THE DOCTOR ADVISED THE PATIENT TO STOP USING OMNIPOD FOR THE NEXT 3 MONTHS. THE POD WAS DISCARDED BY THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1815465 OMNIPOD 5 AUTOMATED INSULIN DELIVERY SYSTEM ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-000438

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female