BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3970134 · Received April 29, 2014

    Report

    Report Number
    3004464228-2014-00566
    Event Type
    Malfunction
    Date Received
    April 29, 2014
    Date of Event
    March 31, 2014
    Report Date
    April 1, 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 DETERMINE IF ANY PRODUCT DEFECT COULD HAVE CONTRIBUTED. THE CUSTOMER REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE, A CONDITION WHICH 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 THAT SHE APPLIED THE POD ON HER ABDOMEN AT 3 PM AND HER BLOOD GLUCOSE WAS IN NORMAL RANGE UNTIL 8 PM WHEN IT MEASURED 400 MG/DL. SHE NOTICED AT THAT TIME THAT THE CANNULA HAD DISLODGED AND CHANGED THE POD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255547 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14810-5E L40788

    Patients

    Seq Age Sex Outcome Treatment
    1