BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4962250 · Received August 3, 2015

    Report

    Report Number
    2032227-2015-24443
    Event Type
    Malfunction
    Date Received
    August 3, 2015
    Date of Event
    July 3, 2015
    Report Date
    July 13, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT HAD UNRESPONSIVE BUTTONS DUE TO CORRODED KEYPAD TRACES. UNABLE TO PERFORM OPERATING CURRENT TEST OR VERIFY BATTERY OUT LIMIT DUE TO UNRESPONSIVE BUTTONS. NO UNEXPECTED NUMBERS RAMPING/SCROLLING DURING TESTING. NO MOISTURE DAMAGE ON ELECTRONIC ASSEMBLY DURING VISUAL INSPECTION. UNIT HAD MINOR SCRATCHED LCD WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNERS, CRACKED BATTERY TUBE THREADS, AND CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS EXPOSED TO MOISTURE WHILE HE WAS GOLFING. THE INSULIN PUMP ALARMED BATTERY OUT LIMIT. HE WAS UNABLE TO REVIEW THE ALARM HISTORY OR CLEAR THE BATTERY OUT LIMIT ALARM BECAUSE THE KEYPAD WAS UNRESPONSIVE. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 171 MG/DL. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACKUP PLAN. THE CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED AND AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505054 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR