BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2251802 · Received August 31, 2011

    Report

    Report Number
    3004464228-2011-00506
    Event Type
    Malfunction
    Date Received
    August 31, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 4, 2011
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE POD WAS RETURNED FOR EVALUATION WITH THE NEEDLE UN-DEPLOYED. THE INVESTIGATION CONFIRMED THAT THE NEEDLE MECHANISM HAD NOT FIRED DUE TO A COMPONENT BEING INSTALLED INCORRECTLY. AS A RESULT OF THE NEEDLE MECHANISM FAILURE, THE CANNULA WOULD NOT HAVE DEPLOYED INTO THE CUSTOMER'S SKIN. BASED ON INVESTIGATION RESULTS, THE POD HAD MALFUNCTIONED DUE TO A MANUFACTURING ERROR AND WOULD HAVE DIRECTLY CONTRIBUTED TO THE CUSTOMER'S HIGH BG LEVELS. THE OMNIPOD USER GUIDE WARNS "CHECK THE INFUSION SITE AFTER INSERTION TO ENSURE THAT THE CANNULA WAS PROPERLY INSERTED." IF USER GUIDE INSTRUCTIONS WERE FOLLOWED, THE CUSTOMER WOULD HAVE IMMEDIATELY NOTICED THAT THE CANNULA HAD NOT DEPLOYED (WHICH WOULD HAVE BEEN VISIBLE THROUGH THE VIEWING WINDOW) AND WOULD NOT HAVE PROCEEDED TO WEAR THE POD. THE USER GUIDE ALSO WARNS THE USER TO "CHECK THE INFUSION SITE OFTEN TO MAKE SURE THE POD AND SOFT CANNULA ARE SECURELY APPLIED AND IN PLACE. IT THE CANNULA IS NOT PROPERLY INSERTED, HYPERGLYCEMIA MAY RESULT". INSULET HAS INITIATED AN INTERNAL INVESTIGATION TO IDENTIFY THE ROOT CAUSE OF THIS FAILURE MODE AND TO MINIMIZE AND PREVENT ITS RECURRENCE. THE INVESTIGATION IS IN-PROCESS AS OF THE DATE OF THIS REPORT. A REVIEW OF LOT QUALIFICATION RECORDS REVEALED ZERO MALFUNCTIONS ASSOCIATED WITH A FAILURE OF THE NEEDLE MECHANISM TO DEPLOY - THE LOT PASSED THE ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    THE CUSTOMER HAD APPLIED A NEW POD IN THE EARLY MORNING; HIS BG LEVEL AT THE TIME WAS LOW (42 MG/DL). OVER THE COURSE OF THE FOLLOWING FOUR HOURS HIS LEVELS BEGAN TO INCREASE CONSISTENTLY, RESULTING IN A HIGH BG OF 255 MG/DL. HE ADMINISTERED A CORRECTION BOLUS IN RESPONSE TO THE HIGH BG, THOUGH HIS LEVELS CONTINUED TO RISE OVER THE FOLLOWING HOUR (UP TO 276 MG/DL). A MANUAL INSULIN INJECTION WAS ADMINISTERED VIA PEN, RESULTING IN HIS BG LEVELS SUCCESSFULLY LOWERING (DOWN TO 240 MG/DL). THE POD WAS DEACTIVATED AND WILL BE RETURNED FOR EVALUATION. UPON INSPECTING THE DEVICE, THE CUSTOMER NOTICED THAT "THE CANNULA WAS NOT OUT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L30525

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR