BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD 5 AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 21250976 · Received January 28, 2025

    Report

    Report Number
    3004464228-2025-03926
    Event Type
    Injury
    Date Received
    January 28, 2025
    Date of Event
    January 7, 2025
    Report Date
    February 7, 2025
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    10385083000138
    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

    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.

    Additional Manufacturer Narrative · 0

    DURING A FOLLOW UP CALL ON (B)(6) 2025, THE PATIENT PROVIDED THE NAME OF THE ANTIBIOTICS PRESCRIBED. SECTION B5 - DESCRIBE EVENT OR PROBLEM HAS BEEN UPDATED TO INCLUDE THE NAME OF THE ANTIBIOTIC.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE POD¿S INSERTION SITE WHILE WEARING THE DEVICE BETWEEN 5 AND 24 HOURS. THE PATIENT NOTICED THE SITE APPEARED SWOLLEN AND PAINFUL. THE PATIENT CALLED BRAMPTON MEDICAL CENTER LOCATED AT 4 MARKET PL, BRAMPTON CA8 1NL, UK (PART OF THE GROVE MEDICAL CENTER) AND WAS PRESCRIBED ANTIBIOTICS FOR TREATMENT. THE PATIENT DOES NOT RECALL THE NAME OF THE ANTIBIOTIC PRESCRIBED. THE POD WAS DISCARDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE POD¿S INSERTION SITE WHILE WEARING THE DEVICE BETWEEN 5 AND 24 HOURS. THE PATIENT NOTICED THE SITE APPEARED SWOLLEN AND PAINFUL. THE PATIENT CALLED BRAMPTON MEDICAL CENTER LOCATED AT (B)(6) UK (PART OF THE (B)(6) MEDICAL CENTER) AND WAS PRESCRIBED CLARITHROMYCIN ANTIBIOTICS FOR TREATMENT. THE POD WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1549253 OMNIPOD 5 AUTOMATED INSULIN DELIVERY SYSTEM ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-000438 10385083000138

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Male