BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAS

    MDR report key: 7338939 · Received March 14, 2018

    Report

    Report Number
    3004209178-2018-56733
    Event Type
    Malfunction
    Date Received
    March 14, 2018
    Date of Event
    October 12, 2017
    Report Date
    March 14, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    00643169513914
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP HAD BLANK DISPLAY DUE TO MOISTURE DAMAGE ON LCD BOARD AND MB. UNABLE TO PERFORM IDLE CURRENT TEST, RUN CURRENT TEST, SELF TEST, OFF NO POWER TEST, DISPLACEMENT TEST AND SENSOR TEST DUE TO BLANK DISPLAY. THE PUMP WAS RECEIVED WITH MINOR SCRATCHED DISPLAY WINDOW AND CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP¿S SCREEN WAS BLANK. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 156 MG/DL. THE CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED AND AGREED TO RETURN THE INSULIN PUMP FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180499 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAS PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAS A5723LNASJ 00643169513914

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR