BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2251790 · Received August 31, 2011

    Report

    Report Number
    3004464228-2011-00492
    Event Type
    Malfunction
    Date Received
    August 31, 2011
    Date of Event
    August 15, 2011
    Report Date
    August 15, 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 WILL NOT RETURNED FOR EVALUATION - WE ARE UNABLE TO IDENTIFY ANY DEVICE MALFUNCTION THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE CUSTOMER'S HIGH BG LEVELS. NO MECHANICAL ISSUE CAN BE CONFIRMED. ALTHOUGH NO MECHANICAL ISSUE CAN BE CONFIRMED, IT IS DETERMINED THAT THE CUSTOMER'S HIGH BG LEVELS HAD RESULTED FROM THE CANNULA PULLING FROM THE INSERTION SITE. THIS CONDITION IS CONSIDERED TO BE A FAILURE OF THE DEVICE TO FUNCTION AS INTENDED (BY FAILING TO CONTROL BG LEVELS). FOR THIS REASON, WE ARE CONSIDERING A DEVICE MALFUNCTION TO HAVE BEEN A CONTRIBUTING FACTOR TO THE CUSTOMER'S HIGH BG LEVELS (DESPITE THE INABILITY TO CONFIRM ANY MECHANICAL ISSUE). THE OMNIPOD SYSTEM USER GUIDE WARNS: "CHECK THE INFUSION SITE AFTER INSERTION TO ENSURE THAT THE CANNULA WAS PROPERLY INSERTED. IT IS ALSO A GOOD IDEA TO CHECK YOUR BLOOD GLUCOSE ABOUT TWO HOURS AFTER EACH POD CHANGE AND TO CHECK THE INFUSION SITE PERIODICALLY. IF THE CANNULA IS NOT PROPERLY INSERTED, HYPERGLYCEMIA MAY RESULT." A REVIEW OF LOT QUALIFICATION RECORDS WAS PERFORMED - THE LOT PASSED THE ACCEPTANCE CRITERIA. EVALUATION METHOD: SPECIFIC TO ACTIVITIES PERFORMED DURING LOT QUALIFICATION AND NOT TO ACTIVITIES PERFORMED ON THE SUBJECT POD (AS IT WAS NOT RETURNED FOR EVALUATION). EVALUATION CONCLUSIONS: PERTAINS TO A FAILURE OF THE CANNULA TO REMAIN INSERTED IN THE CUSTOMER'S SKIN (NOT TO A "MECHANICAL" FAILURE DETECTED DURING TESTING, AS THE POD WAS NOT RETURNED).

    Description of Event or Problem · 1

    THE CUSTOMER CALLED TO REPORT THAT THE CANNULA "CAME OUT DURING THE NIGHT." WHEN SHE WOKE THE FOLLOWING MORNING, HER BG LEVELS HAD RISEN TO "OVER 500MG/DL." NO REASON WAS PROVIDED AS TO HOW THE CANNULA MAY HAVE BECOME DISPLACED. NO ADDITIONAL INFORMATION ABOUT THE POD OR THE EVENT WAS PROVIDED. THE POD WILL NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L30552

    Patients

    Seq Age Sex Outcome Treatment
    1 Other