BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3881288 · Received February 18, 2014

    Report

    Report Number
    3004464228-2014-00191
    Event Type
    Malfunction
    Date Received
    February 18, 2014
    Date of Event
    January 21, 2014
    Report Date
    January 21, 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 TO 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

    THE CUSTOMER REPORTED THAT SHE PRESSED START ON THE PDM, BUT THE NEEDLE DID NOT DEPLOY EVEN THOUGH SHE THOUGHT IT HAD. THE CUSTOMER'S HUSBAND CHECKED THE SITE AND NOTICED THAT THE CANNULA WAS NOT IN. THE CUSTOMER'S BLOOD GLUCOSE ROSE TO 260 MG/DL. THE POD WAS WORN BETWEEN 1-4 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101219 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 L40773

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR