BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 4093005 · Received September 5, 2014

    Report

    Report Number
    3004464228-2014-01314
    Event Type
    Malfunction
    Date Received
    September 5, 2014
    Date of Event
    August 8, 2014
    Report Date
    August 8, 2014
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K122953
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVAL. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE TO FIRE OR TO DETERMINE ITS ROOT CAUSE. LOT QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE NEEDLE NEVER DEPLOYED AND THAT HIS BLOOD GLUCOSE WAS OVER 500 MG/DL. THE POD WAS WORN BETWEEN 4 AND 24 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545951 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 L41135

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR