BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3881270 · Received February 18, 2014

    Report

    Report Number
    3004464228-2014-00188
    Event Type
    Malfunction
    Date Received
    February 18, 2014
    Date of Event
    January 2, 2014
    Report Date
    January 21, 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 BENT AND KINKED CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SEE SCANNED PAGE.

    Description of Event or Problem · 1

    THE CUSTOMER'S MOTHER STATED THAT THE CANNULA IS SLIGHTLY BENT AND POSSIBLE KINKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101222 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORP 14000 L40534

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR