BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIIN INFUSION PUMP

    MDR report key: 4213438 · Received October 13, 2014

    Report

    Report Number
    2032227-2014-36919
    Event Type
    Malfunction
    Date Received
    October 13, 2014
    Date of Event
    June 14, 2014
    Report Date
    June 18, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH NO BACK LIGHT DUE TO FAULTY PANEL ON THE LCD DISPLAY. NO COSMETIC DAMAGE NOTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THEIR INSULIN PUMP MAY HAVE A BACKLIGHT ANOMALY. CUSTOMER STATED THEY ARE UNABLE TO VIEW PROGRAMMING INFO DUE TO THE DARKNESS OF THE DISPLAY SCREEN. CUSTOMER STATED THEY DO NOT RECALL ANY SIGNIFICANT EVENTS THAT LED TO THE ALARM OR IF THE DEVICE HAD BEEN DROPPED. ADVISED CUSTOMER TO DISCONTINUE USE OF RESERVOIR AND REVERT TO BACK UP PLAN. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 143 MG/DL AT TIME OF REPORTING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647417 PARADIGM REAL-TIME REVEL INSULIIN INFUSION PUMP OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR