BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 4252908 · Received September 4, 2014

    Report

    Report Number
    3004464228-2014-01312
    Event Type
    Malfunction
    Date Received
    September 4, 2014
    Date of Event
    July 24, 2014
    Report Date
    August 6, 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 PRODUCT WAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO CONFIRM THE REPORTED KINKED CANNULA OR TO DETERMINE WHERE IT CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2014 HIS BLOOD GLUCOSE REACHED 458 MG/DL A HALF A DAY AFTER THE POD WAS ACTIVATED. UPON REMOVAL HE NOTICED THE CANNULA WAS KINKED. HE WAS ABLE TO ACTIVATE A NEW POD AND GAVE A CORRECTIONAL BOLUS OF INSULIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539759 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORP 14810-5E L40950

    Patients

    Seq Age Sex Outcome Treatment
    1