BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3980906 · Received July 21, 2014

    Report

    Report Number
    3004464228-2014-01032
    Event Type
    Injury
    Date Received
    July 21, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 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 HOSPITALIZATION. QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    THE PATIENT REPORTED HIS BLOOD GLUCOSE REACHED 50.0 MMOL/L (900 MG/DL) LESS THAN 48 HOURS AFTER THE POD WAS ACTIVATED AND HE HAD TO BE HOSPITALIZED FOR NINE WEEKS (3 DAYS IN THE INTENSIVE CARE UNIT) BEFORE BEING RELEASED FROM THE HOSPITAL. THEY TREATED HIM WITH AN INFUSION OF 8 LITERS OF NACL, INSULIN AND MORPHINE FOR HIS PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426677 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14810-5J L40667

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| O