BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3925156 · Received June 20, 2014

    Report

    Report Number
    3004464228-2014-00847
    Event Type
    Malfunction
    Date Received
    June 20, 2014
    Date of Event
    May 26, 2014
    Report Date
    May 26, 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. WE ARE UNABLE TO CONFIRM THE REPORTED KINKED 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 HER BLOOD GLUCOSE AND INSULIN HISTORY IS AS FOLLOWS: TIME: 7:00 AM; BG (MMOL/L): 9.9; (MG/DL) 178; BOLUS (U) 2.10. TIME: 12:58 PM; BG (MMOL/L) 17.4; (MG/DL) 313.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363128 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 15880 L40845

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR