BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3854839 · Received May 22, 2014

    Report

    Report Number
    3004464228-2014-00707
    Event Type
    Injury
    Date Received
    May 22, 2014
    Date of Event
    April 5, 2014
    Report Date
    April 28, 2014
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K122953
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 THE REPORTED ER VISIT FOR DIABETIC KETOACIDOSIS. NO LOT QUALIFICATION RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER'S FATHER REPORTED THAT THE CUSTOMER WENT INTO DIABETIC KETOACIDOSIS (DKA) SO HE WAS TAKEN TO THE ER WHERE HE WAS TREATED WITH AN IV DRIP. THE CUSTOMER'S FATHER ALSO REPORTED THAT HE COULD SMELL INSULIN ON THE POD. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306785 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 L40808

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Other