BEUDAMED
    FDA Adverse Event Other Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1914117 · Received November 24, 2010

    Report

    Report Number
    3004464228-2010-01401
    Event Type
    Other
    Date Received
    November 24, 2010
    Date of Event
    October 28, 2010
    Report Date
    October 28, 2010
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THE CANNULA HAD DEPLOYED 45 MINUTES AFTER THE POD WAS FIRST APPLIED. THIS INDICATES THAT THE NEEDLE MECHANISM POSSIBLY MALFUNCTIONED DUE TO A DAMAGED COMPONENT. SINCE THE POD WAS NOT RETURNED FOR EVAL, HOWEVER, NO MALFUNCTION CAN BE CONFIRMED. THE OMNIPOD USER GUIDE INSTRUCTS USERS TO "CHECK THE INFUSION SITE AFTER INSERTION" TO ENSURE THAT THE CANNULA IS SEATED PROPERLY. IF LABELING INSTRUCTIONS WERE PROPERLY FOLLOWED, THE USER WOULD HAVE NOTICED THAT THE CANNULA HAD NOT FIRED AND WOULD HAVE IMMEDIATELY DEACTIVATED THE DEVICE. DESPITE THE CANNULA REPORTEDLY FIRING 45 MINUTES AFTER THE POD WAS APPLIED, THE CUSTOMER PROCEEDED TO WEAR THE DEVICE OVERNIGHT. THE DEVICE WAS NOT REMOVED UNTIL THE NEXT MORNING, AFTER THE CUSTOMER EXPERIENCED HIGH BG READINGS. THE USER GUIDE ALSO ADVISES USERS TO CHECK THEIR BLOOD GLUCOSE LEVELS FREQUENTLY SO THEY'RE ABLE TO REACT QUICKLY AND APPROPRIATELY TO ANY ISSUES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE NEITHER HEARD NOR FELT THE CANNULA INSERT WHEN A NEW POD WAS APPLIED; SHE "JUST ASSUMED THAT IT WAS IN ALREADY". FORTY-FIVE MINUTES LATER, SHE "FELT THE CANNULA DEPLOY INTO HER SKIN." DESPITE THE DELAYED DEPLOYMENT OF THE CANNULA, SHE PROCEEDED TO WEAR THE POD OVERNIGHT. SHE WOKE UP IN THE MORNING WITH A HIGH BG READING OF 375 MG/DL AND DECIDED TO REMOVE THE POD. THE DEVICE WILL BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L30327

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other