BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 858502 · Received June 1, 2007

    Report

    Report Number
    3004464228-2007-00060
    Event Type
    Malfunction
    Date Received
    June 1, 2007
    Report Date
    June 1, 2007
    Manufacturer
    INSULET CORP
    Product Code
    LZG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT WAS EVALUATED FOR DEFECTS. IT WAS CONFIRMED THAT, THOUGH THE NEEDLE WAS FIRED AS RECEIVED, THE NEEDLE MECHANISM MAY HAVE FAILED TO ACTIVATE IMMEDIATELY DUE TO A MANUFACTURING DEFECT (DAMAGED). THIS WAS THE LIKELY PROBLEM THAT CAUSED THE REPORTED EVENT (ELEVATED BG LEVELS). THE PRODUCT USER GUIDE INSTRUCTS THE USER TO "CHECK THE 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.

    Description of Event or Problem · 1

    CUSTOMER'S MOTHER CALLED TO REPORT POD THAT SHE DID NOT THINK WAS DELIVERING INSULIN. SHE SAID THAT SINCE LAST NIGHT HER DAUGHTER'S BG'S HAVE BEEN STEADILY RISING AND HAVE NOT BEEN COMING DOWN AFTER ADMINISTERING BOLUSES. SHE SAID THAT HER DAUGHTER WOKE UP WITH A SLIGHT FEVER AND MAY HAVE BEEN EXPOSED TO SOME ILLNESS, ALTHOUGH SHE IS NOT SURE. SHE SAID THAT ONCE THEY REMOVED POD, CANNULA DID NOT APPEAR BENT. SHE ALSO MENTIONED THAT SHE DID A BOLUS TEST ON THE POD AND INSULIN WAS COMING OUT OF THE CANNULA. SHE REPORTED THAT BETWEEN 10:30AM - 12:30PM, HER DAUGHTER'S BG LEVELS RANGED BETWEEN 251-400. SHE SAID THEY FINALLY REMOVED POD SINCE BG'S WERE NOT COMING DOWN AFTER GIVING BOLUSES. SHE SAID THAT SHE THINKS THAT HER POD IS NOT WORKING AS HER BG'S CAME DOWN AFTER GIVING A MANUAL SHOT. THE PRODUCT INVOLVED IN THE REPORTED EVENT 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 CORP 11200 L10910

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other