BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2781608 · Received October 10, 2012

    Report

    Report Number
    3004209178-2012-90020
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 29, 2012
    Report Date
    September 29, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PATIENT

    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP HAD FROZEN SCREEN. PROBLEM ISOLATED TO MOTHER BOARD. UNABLE TO TEST FOR BUTTON/KEYPAD UNRESPONSIVENESS, BATTERY OUT LIMIT ALARM OR TIME/CLOCK ANOMALY DUE TO FROZEN SCREEN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP HAD BATTERY ALARMS. THE BLOOD GLUCOSE READING WAS 117MG/DL. TROUBLESHOOTING WAS PERFORMED. THE CALLER STATED THAT THE NUMBERS ARE RAMPING ON THEIR OWN. ADVISED THE CUSTOMER THAT THE UP AND DOWN ARROW MAY BE STUCK. THE CALLER ALSO MENTIONED THAT THE BUTTONS ARE UNRESPONSIVE, AND THE DEVICE HAD A FROZEN DISPLAY. INSTRUCTED THE CUSTOMER TO REMOVE THE BATTERY AND TO INSERT A NEW BATTERY, BUT THE DEVICE STILL HAD FROZEN DISPLAY, AND THE TIME WAS NOT ADVANCING. ADVISED THE CALLER TO REMOVE THE BATTERY FOR TWO HOURS AND TO RE-INSTALL THE BATTERY, BUT THE DEVICE KEPT HAVING FROZEN DISPLAY. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR