BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 4201426 · Received September 17, 2014

    Report

    Report Number
    3004464228-2014-01384
    Event Type
    Malfunction
    Date Received
    September 17, 2014
    Date of Event
    August 18, 2014
    Report Date
    August 18, 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. THE CUSTOMER REPORTED THAT THE CANNULA DISLODGED FROM THE INFUSION SITE, A CONDITION WHICH COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE THE HYPERGLYCEMIA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HER BLOOD GLUCOSE REACHED 19.4 MMOL/L (349 MG/DL) AFTER WEARING THE POD FOR LONGER THAN 48 HOURS AND THAT THE CANNULA WAS OUT OF HER SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577259 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14810-5J L40967

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR