BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4141294 · Received October 3, 2014

    Report

    Report Number
    2032227-2014-06818
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    July 9, 2014
    Report Date
    April 12, 2024
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ISSUES WITH THE KEYPAD ON HER INSULIN PUMP. CUSTOMER'S BLOOD GLUCOSE WAS 166 MG/DL. TROUBLESHOOTING FOUND THE DOWN ARROW BUTTON DOES NOT WORK ALL THE TIME. CUSTOMER COULD NOT RECALL ANY SIGNIFICANT EVENTS LEADINGS TO THE KEYPAD ISSUES. CUSTOMER ALSO STATED THIS WAS A BRAND NEW INSULIN PUMP THAT WAS JUST OPENED TODAY. CUSTOMER WAS ADVISED TO DISCONNECT FROM THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. NO ADDITIONAL INFORMATION IS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619950 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC MINIMED MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male