BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2033061 · Received February 28, 2011

    Report

    Report Number
    3004464228-2011-00092
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    January 30, 2011
    Report Date
    January 30, 2011
    Manufacturer
    INSULET CORP
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATED THAT THE NEEDLE DID NOT RETRACT AFTER FIRING AND 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 SEALED PROPERLY. IF LABELING INSTRUCTIONS WERE PROPERLY FOLLOWED, THE USER WOULD HAVE NOTICED IMMEDIATELY THAT THE NEEDLE HADN'T RETRACTED AND THAT THE CANNULA DIDN'T DEPLOY (WHICH WOULD HAVE BEEN VISIBLE THROUGH THE POD'S VIEWING PORT) AND WOULD HAVE DEACTIVATED THE DEVICE. WITHOUT THE POD RETURNED FOR EVAL; HOWEVER, IT CANNOT BE CONFIRMED THAT A NEEDLE MECHANISM FAILURE WAS THE CAUSE OF THE CUSTOMER'S HIGH BG LEVELS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HE EXPERIENCED CONSECUTIVE BLOOD GLUCOSE READINGS GREATER THAN 500MG/DL WHILE WEARING THIS POD. HE REMOVED THE DEVICE AND "SAW THAT THE NEEDLE HAD NOT RETRACTED AND THE CANNULA HAD NOT DEPLOYED." THE POD 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 CORP 11200 L30451

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other