BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 6072113 · Received November 2, 2016

    Report

    Report Number
    3004464228-2016-03478
    Event Type
    Injury
    Date Received
    November 2, 2016
    Date of Event
    September 19, 2016
    Report Date
    October 7, 2016
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385081120002
    PMA / PMN Number
    K122953
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. 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. THE OMNIPOD USER GUIDE WARNS "IF AN INFUSION SITE SHOWS SIGNS OF INFECTION IMMEDIATELY REMOVE THE POD AND APPLY A NEW ONE AT A DIFFERENT SITE. CONTACT YOUR HEALTHCARE PROVIDER AND TREAT THE INFECTION ACCORDING TO INSTRUCTIONS FROM YOUR HEALTHCARE PROVIDER," AND ADVISES "CHECK THE SITE FOR SIGNS OF INFECTION, SUCH AS PAIN, SWELLING, REDNESS, DISCHARGE OR HEAT."

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THEY DEVELOPED AN INFECTION AT THE INSERTION SITE WHILE WEARING THE POD BETWEEN 36 AND 48 HOURS. THE PATIENT WENT TO THE EMERGENCY ROOM AND WAS DIAGNOSED WITH CELLULITIS. THE PATIENT WAS TREATED WITH ROSTEFTIN (IV ANTIBIOTIC) AND ALSO PRESCRIBED AN ORAL ANTIBIOTIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724160 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 20385081120002

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Hospitalization| R