BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3854865 · Received May 20, 2014

    Report

    Report Number
    3004464228-2014-00682
    Event Type
    Injury
    Date Received
    May 20, 2014
    Date of Event
    April 24, 2014
    Report Date
    April 24, 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 MALFUNCTION OR OTHER PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED HOSPITALIZATION FOR HYPERGLYCEMIA. NO LOT QUALIFICATION RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER'S MOTHER REPORTED THAT HER SON WAS HOSPITALIZED WITH HIGH BLOOD GLUCOSE LEVELS AND HIGH LEVELS OF KETONES. THE CUSTOMER WAS TREATED WITH A DEXTROSE SALINE DRIP. SHE ALSO STATED THAT THE CUSTOMER HAD BEEN VOMITING AND HAD BEEN LOSING CONSCIOUSNESS. SHE COULD NOT RECOLLECT THE EXACT DATE OF THE HOSPITALIZATION, ONLY THAT IT WAS TWO WEEKS PRIOR TO (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300631 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 L40589

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Hospitalization