BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3974226 · Received August 1, 2014

    Report

    Report Number
    2032227-2014-05311
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP HAD INTERMITTENT BUTTON RESPONSE DUE TO A FLATTENED BUTTON DOME SWITCH. NO NUMBER RAMPING OR SCROLL BAR ANOMALY WAS NOTED. ALL OPERATING CURRENTS WERE WITHIN SPECIFICATION. NO UNEXPECTED LOW BATTERY, OFF NO POWER ALARM OR FAILED BATTERY TEST ALARM WAS NOTED. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHES ON THE DISPLAY WINDOW, CRACKED RESERVOIR TUBE LIP AND CRACKED BATTERY TUBE THREADS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE INSULIN PUMP HAD STOPPED WORKING. THE BLOOD GLUCOSE READING WAS 178 MG/DL. HE STATED THAT THE BLOOD GLUCOSE WAS NOT TRANSMITTED TO THE INSULIN PUMP AND THAT HE HAD TO ENTER IT MANUALLY. HE STATED THAT WHEN HE COULD TRY TO DO SO, THE NUMBERS BEGAN SCROLLING WITHOUT FURTHER INPUT. HE CHANGED THE BATTERY AND RECEIVED A FAILED BATTERY TEST ALARM. CUSTOMER COULD NOT RECALL ANY SIGNIFICANT EVENT LEADING TO THIS KEYPAD ISSUE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449900 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR