BEUDAMED
    FDA Adverse Event Other Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1920579 · Received December 7, 2010

    Report

    Report Number
    3004464228-2010-01416
    Event Type
    Other
    Date Received
    December 7, 2010
    Date of Event
    November 5, 2010
    Report Date
    November 5, 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 STATED THAT THE CANNULA HAD NOT DEPLOYED FROM THE POD. 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 HADN'T DEPLOYED (WHICH WOULD HAVE BEEN VISIBLE THROUGH THE POD'S VIEWING PORT) AND WOULD HAVE IMMEDIATELY DEACTIVATED THE DEVICE. 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 REPORT INDICATED THAT THE CUSTOMER'S BG LEVELS HAD RISEN CONSISTENTLY OVER THE EIGHT HOUR PERIOD THE POD WAS WORN. HE EXPERIENCED HIGH BG'S (356-407 MG/DL) DURING THIS TIME. IN RESPONSE, HE REMOVED THE POD -THIS IS WHEN HE NOTICED THAT THE "CANNULA HAD NOT DEPLOYED." THE POD WILL NOT BE RETURNED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L30366

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other