BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 4170345 · Received September 30, 2014

    Report

    Report Number
    3004464228-2014-01462
    Event Type
    Injury
    Date Received
    September 30, 2014
    Date of Event
    August 24, 2014
    Report Date
    September 4, 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 EVALUATION. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED HOSPITALIZATION FOR DIABETIC KETOACIDOSIS. LOT QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    TIME: (B)(6) 2014, 4:00PM - POD ACTIVATED, BLOOD GLUCOSE (MG/DL), BOLUS (UNITS); (B)(6) 2014, UNK TIME, 320; 9:00AM, 370; 5:01PM, 400, 3.0U; 5:04PM - POD DEACTIVATED. THE CUSTOMER WENT TO THE HOSPITAL WHERE SHE WAS DIAGNOSED WITH DIABETIC KETOACIDOSIS (DKA) AND WAS TREATED WITH FLUIDS AND A POTASSIUM DRIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606888 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 L41019

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization