BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4904193 · Received July 9, 2015

    Report

    Report Number
    3004209178-2015-72681
    Event Type
    Malfunction
    Date Received
    July 9, 2015
    Date of Event
    June 19, 2015
    Report Date
    June 19, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP HAD NO BUTTON RESPONSE DUE TO MOISTURE DAMAGE ON KEYPAD TRACES. OCCLUSION TEST WAS NOT PERFORMED DUE TO BUTTON/KEYPAD ANOMALY. NO MOISTURE DAMAGE WAS FOUND INSIDE OF THE DEVICE. THE DEVICE DID HAVE CRACKED CASE AT DISPLAY WINDOW CORNER, RESERVOIR TUBE LIP, AND MINOR SCRATCHED DISPLAY WINDOW.

    Description of Event or Problem · 1

    CUSTOMER REPORTED VIA PHONE, SHE BELIEVES THERE IS AN ISSUE WITH THE KEYPAD, SINCE THE BUTTONS DO NOT RESPOND WHEN SHE PRESSES THEM. CUSTOMER'S BLOOD GLUCOSE WAS 275 MG/DL. ISSUE IS OCCURRING WITH ALL OF THE BUTTONS AND WHEN SHE PRESSES THE B BUTTON IT DISPLAYS LOW RESERVOIR. THE DEVICE WAS ACCIDENTLY WET, FELL INTO THE SINK, AND IT MAY HAVE CAUSED THE KEYPAD ISSUES. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE, REVERT TO BACK UP PLAN, AND THE DEVICE NEED TO BE REPLACED. SHE AGREED TO RETURN THE DEVICE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444897 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR