BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3955164 · Received July 15, 2014

    Report

    Report Number
    3004464228-2014-01002
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 17, 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 PRODUCT WAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT MALFUNCTION OR OTHER PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA AND ER VISIT. QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    THE PATIENT'S MOTHER REPORTED HER SON'S BLOOD GLUCOSE, CARBOHYDRATE INTAKE AND INSULIN HISTORY IS AS FOLLOWS: AT 11:16 THE POD WAS DEACTIVATED AND DISCARDED. SHE TOOK HIM TO THE EMERGENCY ROOM WHERE HE WAS DIAGNOSED WITH HYPERGLYCEMIA. HIS PH LEVEL IS NORMAL AND KETONES WERE MODERATE. THEY PLACED HIM ON AN INTRAVENOUS THERAPY OF FLUIDS AND 5.0 UNITS OF INSULIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413204 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 L40846

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Other