BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2782160 · Received October 4, 2012

    Report

    Report Number
    3004464228-2012-00500
    Event Type
    Injury
    Date Received
    October 4, 2012
    Date of Event
    September 1, 2012
    Report Date
    September 6, 2012
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION. WE ARE UNABLE TO ASSESS THE PRODUCT CONDITION. QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT MET ALL ACCEPTANCE CRITERIA. LOT L30890 WAS RELEASED TO STERILIZATION ON (B)(6) 2012 AND COMPLETED ON (B)(6) 2012 TO THE STERILITY ASSURANCE LEVEL OF 10-6 AND LAL (PYROGENICITY). THE OMNIPOD USER'S WARNS "POD WITHOUT FRIST USING ASEPTIC TECHNIQUE. THIS MEANS TO WASH YOUR HANDS, CLEAN THE INSULIN VIAL WITH AN ALCOHOL PREP SWAB, CLEAN THE INFUSION SITE WITH SOAP AND WATER, AND KEEP STERILE MATERIALS AWAY FROM ANY POSSIBLE GERMS," CAUTIONS "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 "AT LEAST ONCE A DAY, USE THE POD'S VIEWING WINDOW TO INSPECT THE INFUSION SITE. CHECK THE SITE FOR SIGNS OF INFECTION, SUCH AS PAIN, SWELLING, REDNESS, DISCHARGE, OR HEAT."

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE WEARING THE POD ON HER LEFT ARM WHEN SHE EXPERIENCED PAIN AND DISCOMFORT. AFTER A DAY, SHE REMOVED IT AND NOTICED THE SITE APPEARED SWOLLEN AND IT LOOKED LIGHT PINK. THE POD WAS DISCARDED. SHE WENT TO SEE HER DOCTOR ON (B)(6) 2012. THERE WAS FLUID DRAINING FROM THE SITE AND IT HAD DEVELOPED INTO A LUMP. THE DOCTOR REMOVED TWO SYRINGES FULL OF FLUID, GAVE HER A SHOT OF ROCEPHIN AND ALSO A PRESCRIPTION FOR ORAL LEVAQUIN FOR HER INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L30890

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Other