BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3830383 · Received May 13, 2014

    Report

    Report Number
    3004464228-2014-00623
    Event Type
    Malfunction
    Date Received
    May 13, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 11, 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. THE USER REPORTED THE CANNULA WAS NOT INSERTED CORRECTLY INTO THE INFUSION SITE. THIS CONDITION WOULD INTERRUPT DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA IF IT OCCURRED. QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE.

    Description of Event or Problem · 1

    THE CUSTOMER'S MOTHER REPORTED AT 8:30 PM HER DAUGHTER ACTIVATED A NEW POD AN BY THE NEXT MORNING AT 6:45 AM HER BLOOD GLUCOSE WAS READING 380 MG/DL. SHE STATED THAT DURING THE ACTIVATION PROCESS SHE FELT THE NEEDLE INSERTING AND SHE HEARD THE CLICKING WHEN THE NEEDLE DEPLOYED. HER DAUGHTER WAS COMPLAINING THAT HER SITE FELT "WEIRD" SO SHE CHECKED WITH A FLASHLIGHT AND FOUND THE CANNULA LYING ON TOP OF HER SKIN. THE ADHESIVE PAD WAS NOT WET AND ONCE THE POD WAS REMOVED THE POD STARTED TO ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285398 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 L40633

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR