BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3970013 · Received April 28, 2014

    Report

    Report Number
    3004464228-2014-00563
    Event Type
    Malfunction
    Date Received
    April 28, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 1, 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 PRODUCT WAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO CONFIRM THE REPORTED FAILURE OF THE NEEDLE MECHANISM TO FIRE AND DEPLOY THE CANNULA OR TO DETERMINE ITS ROOT CAUSE. QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE NOTICED THERE WAS A LONG DELAY DURING THE NEEDLE INSERTION AND THE NEEDLE RETRACTION PROCESS. HER BLOOD GLUCOSE REACHED 24.2 MMOL/L (436 MG/DL) LESS THAN 4 HOURS AFTER THE POD WAS ACTIVATED. SHE DOES NOT BELIEVE THAT THE CANNULA WAS INSERTED PROPERLY INTO THE INFUSION SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253367 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 15880 L40735

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR