BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3821406 · Received April 25, 2014

    Report

    Report Number
    3004464228-2014-00549
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Date of Event
    March 29, 2014
    Report Date
    March 29, 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 EVALUATION. WE ARE UNABLE TO CONFIRM THE REPORTED FAILURE OF THE NEEDLE MECHANISM FIRE AND DEPLOY THE CANNULA 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

    CUSTOMER REPORTED THAT THE CANNULA DID NOT DEPLOY AND BLOOD GLUCOSE WAS MID TO HIGH 300 MG/DL TO LOW 400 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251453 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 L40618

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR