BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2251792 · Received August 31, 2011

    Report

    Report Number
    3004464228-2011-00503
    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 WILL NOT BE RETURNED FOR EVALUATION - WE ARE UNABLE TO CONFIRM ANY MECHANICAL FAILURE THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE CUSTOMER'S HIGH BG LEVELS. HOWEVER, THE CUSTOMER HAD NOTICED THAT THE FIRING NEEDLE WAS STILL VISIBLE THROUGH THE VIEW PORT WINDOW. THIS SYMPTOM IS INDICATIVE OF A KNOWN FAILURE MODE THAT CAN RESULT IN A FAILURE OF NEEDLE TO RETRACT AFTER FIRING. A FAILURE OF THE NEEDLE TO RETRACT INTO THE POD CAN CAUSE INSULIN DELIVERY TO BE RESTRICTED OR OBSTRUCTED, POTENTIALLY RESULTING IN HIGH BG LEVELS. THOUGH IT CANNOT BE CONFIRMED THROUGH A DEVICE EVALUATION, WE ARE CONCLUDING THAT THE CUSTOMER'S HIGH BG LEVELS POTENTIALLY RESULTED FROM A FAILURE OF THE NEEDLE MECHANISM TO RETRACT (BASED ON THE REPORTED SYMPTOM). THE OMNIPOD USER GUIDE INSTRUCTS USERS TO "CHECK THE INFUSION SITE AFTER INSERTION." IF LABELING INSTRUCTIONS WERE FOLLOWED, THE CUSTOMER WOULD HAVE NOTICED THAT THE NEEDLE HADN'T FULLY RETRACTED (WHICH WOULD HAVE BEEN VISIBLE THROUGH THE POD'S VIEWING PORT) AND WOULD HAVE IMMEDIATELY DEACTIVATED THE DEVICE. THE CUSTOMER ONLY BECAME AWARE OF THIS CONDITION AFTER BG LEVELS HAD RISEN. (IT IS UNKNOWN HOW LONG THE CUSTOMER HAD WORN THIS POD.) A REVIEW OF LOT QUALIFICATION RECORDS WAS PERFORMED - NO ISSUES RELATED TO NEEDLE MECHANISM FAILURES WERE FOUND. THE LOT PASSED THE ACCEPTANCE CRITERIA. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED SHE WAS EXPERIENCING HIGH BG LEVELS (300MG/DL) AND THEREFORE "IS NOT SURE THAT SHE IS GETTING INSULIN FROM THE POD." DESPITE THE HIGH BG'S, SHE "DID NOT HAVE ANY SYMPTOMS." SHE STATED THAT SHE "IS STILL SEEING THE NEEDLE FROM THE CANNULA WINDOW." 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 45 YR Other