BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 4963837 · Received July 29, 2015

    Report

    Report Number
    3004464228-2015-00362
    Event Type
    Malfunction
    Date Received
    July 29, 2015
    Date of Event
    June 29, 2015
    Report Date
    June 30, 2015
    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 USER REPORTED THAT THE CANNULA DISLODGED FROM THE INFUSION SITE, A CONDITION WHICH COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HIS BLOOD GLUCOSE REACHED 16.9 MMOL/L (304 MG/DL) AND THAT THE CANNULA WAS OUT OF THE SKIN. THE POD WAS WORN BETWEEN 24 AND 36 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495249 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14810 L41287

    Patients

    Seq Age Sex Outcome Treatment
    1