BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 4202255 · Received October 15, 2014

    Report

    Report Number
    3004464228-2014-01544
    Event Type
    Injury
    Date Received
    October 15, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 18, 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 NOT RETURNED FOR EVAL. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED ER VISIT FOR HYPERGLYCEMIA.. LOT QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    SEE SCANNED TABLE. THE CUSTOMER REPORTED THAT SHE CALLED AN AMBULANCE AND WAS TAKEN TO THE ER. SHE WAS DIAGNOSED WITH HYPERGLYCEMIA AND WAS GIVEN IV FLUIDS. SHE ALSO REPORTED TAKING A 4-5 UNIT MANUAL INJECTION OF INSULIN BEFORE THE AMBULANCE ARRIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655251 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 L41166

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Hospitalization