BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1913005 · Received November 18, 2010

    Report

    Report Number
    3004464228-2010-01376
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    October 6, 2010
    Report Date
    October 20, 2010
    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 EVALUATION OF THE RETURNED POD FOUND EVIDENCE OF A BROKEN COMPONENT ON THE DEVICE'S CHASSIS WHICH DIRECTLY RESULTED IN THE FAILURE OF THE NEEDLE MECHANISM TO DEPLOY. THE CUSTOMER'S REPORT THAT THE "CANNULA HAD NEVER INSERTED" CAN THEREFORE BE CONFIRMED. THE USER FAILED TO NOTE THIS CONDITION UPON PLACING THE POD, WHICH WOULD HAVE BEEN VISIBLE THROUGH THE VIEWING PORT. THE OMNIPOD SYSTEM USER GUIDE INSTRUCTS THE USER TO 'CHECK INFUSION SITE FREQUENTLY FOR PROPER CANNULA PLACEMENT". IT ALSO SUGGESTS THAT THE USER SHOULD CHECK THEIR BLOOD GLUCOSE LEVELS FREQUENTLY, SO THAT THEY CAN NOTICE AND REACT QUICKLY AND APPROPRIATELY TO ANY ISSUES. THE PT REMEDIED THE SITUATION BY IMMEDIATELY REMOVING THE DEVICE UPON RECOGNIZING THAT HER BG LEVELS WERE HIGH.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE EXPERIENCED HIGH BG LEVELS (450 MG/DL) WITHIN THE FIRST FOUR HOURS OF APPLYING A NEW POD. BECAUSE OF HER HIGH LEVELS, SHE REMOVED THE POD; THIS IS WHEN SHE "REALIZED THAT THE CANNULA HAD NEVER INSERTED." THE POD 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 L30339

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other