BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3851262 · Received March 26, 2014

    Report

    Report Number
    3004464228-2014-00373
    Event Type
    Malfunction
    Date Received
    March 26, 2014
    Date of Event
    February 23, 2014
    Report Date
    February 24, 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 PRODUCT WAS NOT RETURNED FOR EVALUATION. THE USER REPORTED THE CANNULA WAS NOT INSERTED CORRECTLY INTO THE INFUSION SITE. THIS CONDITION WOULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA IF IT OCCURRED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ON (B)(6) 2014 HIS BLOOD GLUCOSE AND INSULIN HISTORY. THE POD WAS DEACTIVATED AND HE NOTICED THE CANNULA WAS NOT INSERTED INTO THE INFUSION SITE. AT 1:31 AM HE WAS ABLE TO ACTIVATE NEW POD AND GAVE A BOLUS OF 10.0 UNITS OF INSULIN. AT 9:30 AM HIS BG WAS READING 3.2 MMOL/L (58 MG/DL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177665 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 15880 L40735

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR