BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3881267 · Received February 18, 2014

    Report

    Report Number
    3004464228-2014-00198
    Event Type
    Malfunction
    Date Received
    February 18, 2014
    Date of Event
    January 17, 2014
    Report Date
    January 20, 2014
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K122953
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE CUSTOMER REPORTED THAT THE CANNULA MAY NOT HAVE INSERTED PROPERLY INTO THE INFUSION SITE, A CONDITION THAT COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HIS BLOOD GLUCOSE REACHED 23.6 MMOL/L (425 MG/DL) LESS THAN FOUR HOURS AFTER THE POD WAS ACTIVATED AND THAT THE CANNULA WAS OUT OF THE SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101374 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14810-5J L40556

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR