BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3984361 · Received August 6, 2014

    Report

    Report Number
    3004209178-2014-90509
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    July 6, 2014
    Report Date
    July 6, 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

    NO BUTTON ERROR ALARMS WERE NOTED. ARROW BUTTONS DID NOT RESPOND DUE TO CORRODED KEYPAD TRACES. NO MOISTURE DAMAGE ON ELECTRONICS WAS NOTED. THE INSULIN PUMP WAS MONITORED FOR TWO DAYS AND NO BLANK DISPLAY WAS NOTED. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHES ON THE DISPLAY WINDOW, CRACKED DISPLAY WINDOW CORNER, CRACKED BATTERY TUBE THREADS, A BROKEN RESERVOIR TUBE LIP AND A CRACKED RESERVOIR TUBE.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THEIR INSULIN PUMP WAS ALARMING BUTTON ERROR AND THE DISPLAY SCREEN WENT BLANK. CUSTOMER STATED THEY DID NOT RECALL ANY SIGNIFICANT EVENTS THAT LEAD TO THE ALARM OR IF THE DEVICE WAS DROPPED, BUT MENTIONED IT MAY HAVE BEEN EXPOSED TO MOISTURE WHEN IT WAS PLACED NEXT TO A SINK. ADVISED CUSTOMER TO DISCONTINUE USE OF DEVICE AND REVERT TO BACK UP PLAN. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 340 MG/DL AT TIME OF REPORTING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460746 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR