BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3931382 · Received April 11, 2014

    Report

    Report Number
    3004464228-2014-00475
    Event Type
    Malfunction
    Date Received
    April 11, 2014
    Date of Event
    March 15, 2014
    Report Date
    March 15, 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 FAILURE OF THE NEEDLE MECHANISM TO DEPLOY THE CANNULA OF 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 WHEN THE POD WAS ACTIVATED, HER BLOOD GLUCOSE (BG) LEVEL WAS 168 MG/DL. AFTER 7 HOURS, HER BG'S REACHED 340 MG/DL AND THERE WAS BLOOD AROUND THE EDGE OF THE ADHESIVE. WHEN THE POD WAS REMOVED, SHE NOTICED THAT THE CANNULA HAD NEVER DEPLOYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220077 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 1400 L40576

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR