BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2212069 · Received July 8, 2011

    Report

    Report Number
    2032227-2011-01643
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    June 21, 2011
    Report Date
    June 21, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP HAD A BLANK DISPLAY DUE TO MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY. THE INSULIN PUMP HAD MOISTURE DAMAGE ON THE MOTOR. THE INSULIN PUMP HAD CORRODED KEYPAD TRACES. UNABLE TO TEST FOR THE FROZEN SCREEN, BATTERY OUT LIMIT ALARM, BUTTON/KEYPAD ANOMALY, TIME CLOCK ANOMALY OR THE OPERATING CURRENTS DUE TO THE BLANK DISPLAY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A BATTERY OUT LIMIT ALARM. TROUBLESHOOTING WAS ATTEMPTED, BUT THE SCREEN FROZE, AND THE BUTTONS WOULD NOT CLEAR THE ALARM. THE TIME ON THE SCREEN WAS NOT ADVANCING EITHER. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC MINIMED MMT-523LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR