BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3833364 · Received May 16, 2014

    Report

    Report Number
    3004464228-2014-00678
    Event Type
    Injury
    Date Received
    May 16, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 7, 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 HYPOGLYCEMIA AND HOSPITALIZATION. QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT HE WAS HOSPITALIZED FOR BLOOD GLUCOSE READING OF 2.4 MMOL/L (43 MG/DL). AT THE HOSPITAL HE WAS TREATED WITH GLUCAGON AND HE WAS GIVEN 10CC OF SUGAR WATER. HE WAS AT THE HOSPITAL FOR A FEW HOURS BEFORE BEING RELEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293354 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14810-5J L40716

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other