BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8643400 · Received May 27, 2019

    Report

    Report Number
    2032227-2019-07041
    Event Type
    Malfunction
    Date Received
    May 27, 2019
    Date of Event
    January 29, 2019
    Report Date
    May 26, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    00643169513914
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP HAD UNRESPONSIVE BUTTONS DUE TO FLATTENED (CREASED) ALL BUTTONS DOME SWITCH. NO UNLOCKED J2 OR LCD KEYPAD CONNECTOR NOTED. UNIT HAD STRIPPED BATTERY CAP COIN SLOT (P), CRACKED BATTERY TUBE THREADS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD BATTERY CAP ISSUE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER ALLEGES PUMP WAS NOT ABLE TO REMOVE THE BATTERY CAP ON THE INSULIN PUMP. CUSTOMER STATES THEY WERE NOT ABLE TO REMOVE THE BATTERY CAP. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE PUMP IF THE BATTERY IS LOW. THE CUSTOMER WAS ADVISED TO MONITOR THE PUMP CLOSELY IF THEY CONTINUE USE OF THE PUMP. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437647 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 74 YR