BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 4231698 · Received October 14, 2014

    Report

    Report Number
    3004464228-2014-01533
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    September 11, 2014
    Report Date
    September 16, 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 EVAL. WE ARE UNABLE TO CONFIRM THE REPORTED KINK CANNULA OR TO DETERMINE WHETHER 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 ON (B)(6) 2014 HIS BLOOD GLUCOSE REACHED 14.0 MMOL/L (252 MG/DL) AND HE GAVE HIMSELF A CORRECTIONAL BOLUS OF INSULIN (EXACT DOSAGE WAS NOT PROVIDED). UPON INSPECTION, HE NOTICED THE CANNULA WAS KINKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648758 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14810-5E L40901

    Patients

    Seq Age Sex Outcome Treatment
    1