BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3761121 · Received December 31, 2013

    Report

    Report Number
    3004464228-2013-01618
    Event Type
    Malfunction
    Date Received
    December 31, 2013
    Date of Event
    November 19, 2013
    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 EVALUATION. THE CUSTOMER REPORTED THAT THE CANNULA DISLODGED FROM THE INFUSION SITE, A CONDITION WHICH COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. NO QUALIFICATION RECORDS BECAUSE NO PRODUCT LOT NUMBER WAS REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HE APPLIED THE DEVICE ON HIS ABDOMEN ON (B)(6) AND HIS BLOOD GLUCOSE WAS IN NORMAL RANGE UNTIL (B)(6) WHEN IT REACHED 299 MG/DL. HE NOTICED THAT THE CANNULA WAS OUT OF THE TISSUE AND CHANGED THE POD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682886 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14810-5E

    Patients

    Seq Age Sex Outcome Treatment
    1