BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 5151801 · Received October 15, 2015

    Report

    Report Number
    2032227-2015-56939
    Event Type
    Malfunction
    Date Received
    October 15, 2015
    Date of Event
    September 29, 2015
    Report Date
    October 13, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT HAD A BUTTON ERROR ALARM AND AN INTERMITTENT BUTTON RESPONSE DUE TO A CORRODED KEYPAD. THE UNIT HAD A CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, A MINOR SCRATCHED LCD WINDOW, A SCRATCHED RESERVOIR TUBE WINDOW, A CRACKED RESERVOIR TUBE, AND A CRACKED RESERVOIR TUBE WINDOW.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED IN TO REPORT THAT THE INSULIN PUMP ALARMED BUTTON ERROR. THE CUSTOMER COULD NOT RECALL ANY SIGNIFICANT EVENTS LEADING TO THE ISSUE. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. THE CUSTOMER WAS INFORMED THAT THE DEVICE WOULD BE REPLACED, AND WAS INFORMED TO RETURN THE MALFUNCTIONING DEVICE BACK FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682123 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR