BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4193032 · Received October 22, 2014

    Report

    Report Number
    2032227-2014-41778
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    September 23, 2014
    Report Date
    September 23, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. (B)(4).

    Additional Manufacturer Narrative · 1

    ALL OF THE BUTTONS FUNCTIONED PROPERLY AND NO MOISTURE DAMAGE WAS NOTED ON THE KEYPAD TRACES. NO UNLOCKED KEYPAD CONNECTOR WAS NOTED. THE INSULIN PUMP HAD MINOR SCRATCHES ON THE DISPLAY WINDOW, CRACKED BATTERY TUBE THREADS, A BROKEN BELT CLIP SLOT AT THE BATTERY TUBE THREADS AREA AND A CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD AN UNRESPONSIVE KEYPAD ON THE INSULIN PUMP. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 154 MG/DL. CUSTOMER STATED THAT WHEN SHE WAS TRYING TO FILL THE TUBING, IT KEPT ASKING HER TO FILL THE TUBING AND WON'T GO PAST THE "ARE YOU DISCONNECTED" SCREEN. CUSTOMER STATED THAT HER BUTTONS WON'T RESPOND TO HER COMMAND. CUSTOMER WENT TO THE ALARM HISTORY AND THE BUTTONS STOPPED WORKING ON THE PUMP. CUSTOMER STATED THAT WHEN SHE PRESSES THE ESC BUTTON, NOTHING IS HAPPENING. INSULIN PUMP WILL NEED TO BE REPLACED. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672636 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR