BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3970061 · Received April 28, 2014

    Report

    Report Number
    3004464228-2014-00553
    Event Type
    Malfunction
    Date Received
    April 28, 2014
    Date of Event
    March 30, 2014
    Report Date
    March 31, 2014
    Manufacturer
    INSULET CORP.
    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 NEEDLE MECHANISM FAILURE TO INJECT THE CANNULA OR TO DETERMINE ANY 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 HIS BLOOD GLUCOSE ROSE TO 301 MG/DL ABOUT 2 HOURS AFTER THE POD WAS ACTIVATED. WHEN HE REMOVED THE POD, HE NOTICED THAT THE CANNULA NEVER INJECTED INTO THE SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253436 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORP. 14000 L40831

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR