BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4243970 · Received November 11, 2014

    Report

    Report Number
    2032227-2014-50368
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 14, 2014
    Report Date
    October 14, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FAILED BATT TEST ALARM, OFF NOW POWER ALARM, AND BATTERY OUT LIMIT ALARM WAS NOT VERIFIED DUE TO BLANK DISPLAY NOTED. DISPLACEMENT, OPERATING CURRENTS, AND OFF NO POWER TESTS WERE NOT PERFORMED DUE TO BLANK DISPLAY. THE INSULIN HAD A BLANK DISPLAY DUE TO SLIGHTLY CORRODED BATTERY TUBE AND SEVERELY CORRODED BATTERY CAP CONTACT. MINOR SCRATCHES ON LCD WINDOW, CRACKED RESERVOIR TUBE LIP, SCRATCHES ON RESERVOIR TUBE WINDOW, CRACKED RESERVOIR TUBE, AND CRACKED BATTERY TUBE THREADS.

    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD A NO POWER ALARM ON THE INSULIN PUMP. THE PUMP HAD BEEN TURNING OFF AND WAS NOT TAKING ANY BATTERIES. CUSTOMER RECEIVED A FAILED BATTERY TEST ON SUNDAY AND IT WAS NOT THE NORMAL LOW BATTERY ALARM. CUSTOMER REPLACED THE BATTERY AND IT WAS FINE. CUSTOMER RECEIVED AN OFF/NO POWER ALARM TODAY AND WHEN SHE CHANGED THE BATTERY, THERE WAS A BLANK SCREEN. CUSTOMER WAS USING A (B)(6) BATTERY. CUSTOMER DID NOT RECEIVE A LOW BATTERY ALERT PRIOR TO THE OFF/NO POWER ALERT. CUSTOMER STATED THAT THE BATTERY CAP WAS LOOSE. CUSTOMER IS BEING SENT A BATTERY CAP REPLACEMENT. TROUBLESHOOTING WAS PERFORMED, BUT THE DISPLAY DID NOT RETURN. CUSTOMER WAS ASSISTED WITH CLEARING THE BATTERY OUT LIMIT ALARM. CUSTOMER WAS TOLD THAT THIS WAS NORMAL PUMP BEHAVIOR. CUSTOMER RECEIVED A FAILED BATTERY TEST AFTER INSERTING A NEW AAA ALKALINE BATTERY. CUSTOMER WAS ADVISED TO MONITOR THE PUMP. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726129 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR