BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3930608 · Received July 12, 2014

    Report

    Report Number
    3004209178-2014-86839
    Event Type
    Malfunction
    Date Received
    July 12, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS SHOWED UNIT PASSED FUNCITON TESTING, INCLUDING THE REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST, NO DELIVERY TEST AND DISPLACEMENT TEST. THE UNIT ALARMED BUTTON ERROR FOLLOWED BY INTERMITTENT BUTTONS DUE TO CORRODED KEYPAD TRACES. THE UNIT ALSO HAD A SCRATCHED LCD WINDOW.

    Description of Event or Problem · 1

    CUSTOMER CALLED STATING THAT HE WOKE UP WITH HIS INSULIN PUMP ALARMING BUTTON ERROR. YESTERDAY HE WAS BLOOD GLUCOSE LEVELS RANGING BETWEEN 400 MG/DL AND 600 MG/DL. CUSTOMER'S CURRENT BLOOD GLUCOSE LEVEL IS 400 MG/DL. THERE WERE NO SIGNIFICANT EVENTS LEADING UP TO THE ALARM. CUSTOMER WAS ADVISED THAT THE DEVICE NEEDS TO BE REPLACED, AND TO DISCONTINUE USE OF THE DEVICE AND REVERT TO HIS BACK UP PLAN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408820 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR