BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3926244 · Received July 1, 2014

    Report

    Report Number
    3004464228-2014-00904
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    May 28, 2014
    Report Date
    June 2, 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 RETURNED FOR EVALUATION. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED HOSPITALIZATION FOR HYPERGLYCEMIA. LOT QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    THE CUSTOMER'S MOTHER REPORTED THAT THE PDM READ HIGH (>500 MG/DL) SO THE CUSTOMER WAS TAKEN TO THE HOSPITAL WHERE HE WAS GIVEN A MANUAL SHOT OF INSULIN AND AN IV. THE CUSTOMER HAD A PANIC ATTACK AND HAD A CHEST X-RAY TAKEN AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382953 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 L40813

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Hospitalization