BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1813191 · Received August 19, 2010

    Report

    Report Number
    3004464228-2010-01250
    Event Type
    Malfunction
    Date Received
    August 19, 2010
    Date of Event
    July 24, 2010
    Report Date
    July 24, 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 PRODUCT WAS RETURNED AND EVALUATED. IT WAS DETERMINED THAT THE CANNULA HAD NOT FIRED DUE TO INTERFERENCE FROM A MISALIGNED COMPONENT. THE USER FAILED TO NOTE THIS CONDITION WHICH WOULD BE VISIBLE THROUGH THE VIEWING PORT UPON POD PLACEMENT IF LABELING IS FOLLOWED. THE PRODUCT 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 REMOVING AND REPLACING THE DEVICE PER USER INSTRUCTIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT, WHEN ACTIVATING THE POD, SHE HEARD IT "CLICK AS IF THE CANNULA INSERTED, BUT IT DIDN'T PINCH LIKE IT NORMALLY DOES". THE POD PROCEEDED TO BE WORN FOR UP TO FOUR HOURS, DURING WHICH TIME, HER BG LEVELS WENT HIGH (500MG/DL). BECAUSE OF THIS, SHE "BECAME AWARE SOMETHING WAS WRONG"; SHE SURMISED THAT THE "NEEDLE DIDN'T PENETRATE THE SKIN AND THE CANNULA DIDN'T INSERT". THE POD WILL RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L30333

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other