BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2251800 · Received August 31, 2011

    Report

    Report Number
    3004464228-2011-00494
    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 BE RETURNED FOR EVALUATION - WE ARE UNABLE TO CONFIRM ANY DEVICE MALFUNCTION THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE CUSTOMER'S HIGH BG LEVELS. IN ADDITION, WE ARE UNABLE TO CONFIRM WHETHER THE REPORTED "SLIGHT BEND/KINK" IN THE CANNULA HAD CONTRIBUTED TO INSUFFICIENT INSULIN DELIVERY. BASED ON THE BG HISTORY PROVIDED BY THE CUSTOMER, HOWEVER, IT IS ASSUMED THAT THE CANNULA KINK WAS A POTENTIAL CONTRIBUTING FACTOR. TWICE, THE CUSTOMER HAD PROGRAMMED CORRECTION BOLUSES IN RESPONSE TO A HIGH BG READING, BUT BOTH TIMES HER BG LEVELS FAILED TO LOWER; IT IS EXPECTED THAT HER BG'S WOULD HAVE GONE DOWN IN RESPONSE TO THE CORRECTION BOLUSES. (WITHOUT THE POD RETURNED FOR EVALUATION, HOWEVER, WE CANNOT CONFIRM WHETHER THE HIGH BG LEVELS WERE DUE TO PHYSIOLOGICAL CONDITIONS OR WHETHER THE REPORTED CANNULA KINK MAY HAVE BEEN A FACTOR.) IN ADDITION, THERE IS NO INDICATION THAT THE POD HAD INITIATED AN OCCLUSION ALARM IN RESPONSE TO THE CANNULA KINK. IF INSULIN FLOW TO THE USER WAS OBSTRUCTED BY THE KINK, THE POD SHOULD HAVE INITIATED AN OCCLUSION ALARM. A REVIEW OF LOT QUALIFICATION TEST RESULTS FOR THIS POD LOT WAS PERFORMED - NO FAILURES RELATED TO A KINKED CANNULA WERE FOUND. THE LOT PASSED THE ACCEPTANCE CRITERIA. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER WAS EXPERIENCING "HIGHER THAN NORMAL BG LEVELS" AND SUSPECTED THAT IT MAY HAVE BEEN DUE TO A "POD ISSUE." SHE HAD ADMINISTERED A CORRECTION BOLUS IN RESPONSE TO A HIGH BG OF 255 MG/DL; 2.5 HOURS LATER, HOWEVER, HER LEVELS REMAINED UNCHANGED. A SECOND CORRECTION BOLUS WAS ADMINISTERED AND 1.5 HOURS LATER HER LEVELS WERE STILL 255 MG/DL. THE POD WAS CHANGED AND "BG LEVELS QUICKLY RETURNED TO NORMAL." THE CANNULA OF THE SUSPECT POD "APPEARED SLIGHTLY BENT/KINKED," THOUGH NO OCCLUSION ALARM HAD BEEN INITIATED. NO PRODUCT WILL 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 L30599

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Other