BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 4120642 · Received July 28, 2014

    Report

    Report Number
    3004464228-2014-01065
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    June 29, 2014
    Report Date
    June 29, 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 BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE HYPERGLYCEMIA. THE USER REPORTED A DISLODGED CANNULA. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ON (B)(6) 2014 AT 11:00 PM HE ACTIVATED A NEW POD AND ON (B)(6) 2014 HIS BLOOD GLUCOSE AND INSULIN HISTORY IS AS FOLLOWS: SEE SCANNED TABLE. HE NOTICED THE CANNULA WAS "DETACHED" FROM HIS SKIN AND IT WAS SLIGHTLY BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439869 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 L40823

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR