BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPON INSULIN PUMP

    MDR report key: 3842649 · Received February 25, 2014

    Report

    Report Number
    3004464228-2014-00222
    Event Type
    Malfunction
    Date Received
    February 25, 2014
    Date of Event
    January 27, 2014
    Report Date
    January 27, 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 BENT 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HAT HE ACTIVATED THE POD AT 6:33PM ON (B)(6) 2014. BY P:22PM, THE CUSTOMER'S BLOOD GLUCOSE HAD RISEN TO 258 MG/DL. WHEN THE POD WAS REMOVED,T HE CUSTOMER NOTICED THAT THE CANNULA WAS BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114911 OMNIPON INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 L40747

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR