BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4182615 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-39697
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    August 23, 2014
    Report Date
    September 19, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    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

    NO BUTTON ERROR ALARM WAS NOTED DURING TESTING. THE INSULIN PUMP HAD INTERMITTENT BUTTON RESPONSE DUE TO CORRODED EXPRESS BOLUS, ESCAPE, ACT, AND DOWN BUTTON KEYPAD TRACES. THE INSULIN PUMP WAS MONITORED FOR SEVERAL DAYS AND NO BLANK DISPLAY AS NOTED. THE INSULIN PUMP HAD NORMAL OPERATING CURRENTS. NO DAMAGE WAS NOTED TO THE ISOLATION TAPE. NO MOISTURE DAMAGE WAS NOTED ON THE ELECTRONIC, MOTOR, VIBRATOR, OR BATTERY TUBE ASSEMBLY DURING THE VISUAL INSPECTION. THE INSULIN PUMP HAD MINOR SCRATCHES ON THE DISPLAY WINDOW, A CRACKED CASE AT THE DISPLAY WINDOW CORNERS, CRACKED RESERVOIR TUBE LIP AND SCRATCHED RESERVOIR TUBE WINDOW.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP ALARMED BUTTON ERROR AND HAD BLANK DISPLAY. CUSTOMER STATED BUTTON ERROR OCCURRED COUPLE OF TIMES. CUSTOMER LEFT THE INSULIN PUMP IN SUSPEND INSIDE THE HOUSE AND GOT BACK AND HAD BUTTON ERROR. TROUBLESHOOTING WAS DONE. CUSTOMER'S BLOOD GLUCOSE WAS 154 MG/DL. CUSTOMER ALSO MENTIONED THAT HE CHANGED THE BATTERY AND THE INSULIN PUMP HAD NO DISPLAY AT ALL. ADVISED CUSTOMER THE INSULIN PUMP WOULD BE REPLACED. ADVISED TO DISCONTINUE USING THE PUMP AND REVERT TO A BACK-UP PLAN PER HEALTH CARE PROVIDER. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660945 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR