BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 5993082 · Received October 3, 2016

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    Report

    Report Number
    3004464228-2016-03082
    Event Type
    Injury
    Date Received
    October 3, 2016
    Date of Event
    August 11, 2016
    Report Date
    September 6, 2016
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    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'S MOTHER REPORTED THAT HER DAUGHTER HAD AN INFECTION AT THE INSERTION SITE. THE PATIENT WENT TO THE DOCTOR AND WAS PRESCRIBED ANTIBIOTIC CEPHALEXIN. THE POD WAS WORN LONGER THAN 48 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646480 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Other| R