BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 4232654 · Received September 12, 2014

    Report

    Report Number
    3004464228-2014-01363
    Event Type
    Malfunction
    Date Received
    September 12, 2014
    Date of Event
    August 16, 2014
    Report Date
    August 16, 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 MALFUNCTION TO FIRE AND DEPLOY THE CANNULA OR TO DETERMINE THE ROOT CAUSE. LOT QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HER BLOOD GLUCOSE REACHED 344 MG / DL LESS THAN 4 HOURS AFTER THE POD WAS ACTIVATED AND GAVE HERSELF A BOLUS OF 4.0 UNITS OF INSULIN. SHE COULD SMELL AND FEEL INSULIN AROUND THE ADHESIVE PAD. UPON DEACTIVATION SHE DID NOT SEE THE PINK SLIDE INSERT IN THE WINDOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564841 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 L41066

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR