BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2823533 · Received August 7, 2008

    Report

    Report Number
    3004464228-2008-00169
    Event Type
    Injury
    Date Received
    August 7, 2008
    Date of Event
    July 10, 2008
    Report Date
    July 10, 2008
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER'S MOM CALLED TO REPORT A POD FAILURE WHILE SLEEPING. THE POD WAS ON HER DAUGHTER'S ABDOMEN. SHE HAD AN OCCLUSION THE EVENING BEFORE ((B)(6) 2008) AND CHANGED THAT POD AT 5:30 PM AND GAVE A 6.35U INSULIN BOLUS. AT 7:30 PM, HER BLOOD GLUCOSE (BG) WAS 194 MG/DL. AT 8 PM, BG WAS 196 MG/DL. SHE WENT TO BED ON (B)(6) 2008 - MOM LET HER SLEEP IN UNTIL 8:30 AM. BG WAS 405 MG/DL, MOTHER GAVE A 7.6U BOLUS. AT 9:50 AM, BG 386 MG/DL AND MODERATE KETONES. AT 10:30 AM BG 402 MG/DL AND LARGE KETONES. A MANUAL INJECTION OF 7.5U WAS GIVEN IN THE ABDOMEN. MOTHER CHANGED POD AT THIS TIME. THE DAUGHTER WAS VERY LETHARGIC AND MOM TOOK HER TO ER WHERE THEY GAVE HER AN IV AND HER BG CAME DOWN. DAUGHTER WAS DOING MUCH BETTER ON (B)(6) 2008. MOTHER SAYS THAT WHEN SHE LOOKED AT THE POD AFTER THE ER VISIT. IT WAS NOT ANGLED LIKE NORMAL. IT WAS MORE STRAIGHT UP AND DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L11696

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Hospitalization