BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3932300 · Received April 4, 2014

    Report

    Report Number
    3004464228-2014-00443
    Event Type
    Malfunction
    Date Received
    April 4, 2014
    Date of Event
    November 22, 2013
    Report Date
    March 26, 2014
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED PRODUCT WAS EVALUATED AND NO EVIDENCE OF ANY MANUFACTURING DEFECT WAS DETECTED. AN AIR BUBBLE, EQUIVALENT TO 5-6 UNITS OF INSULIN IN SIZE, WAS FOUND IN THE INSULIN RESERVOIR. AS THERE WAS NO EVIDENCE THAT THE USER ATTEMPTED TO REMOVE RESIDUAL INSULIN, THIS WAS MOST LIKELY INTRODUCED DURING THE FILL PROCESS. USE ERROR IS THEREFORE DETERMINED TO BE THE ROOT CAUSE OF THE HYPERGLYCEMIA. LOT QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    THE CUSTOMER PLACED THE POD AT 8:30 AM AND HAD A BLOOD GLUCOSE (BG) LEVEL OF 224 MG/DL. AT 12:07 PM, THE CUSTOMER'S BGS WERE 301, AT 3:58 PM THE CUSTOMER'S BGS WERE 376, AND AT 4:30 PM THE CUSTOMER'S BGS WERE HIGH (>500 MG/DL) SO THE CUSTOMER REMOVED THE POD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205337 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L30980

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR