BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4791152 · Received May 22, 2015

    Report

    Report Number
    2032227-2015-16509
    Event Type
    Malfunction
    Date Received
    May 22, 2015
    Date of Event
    May 3, 2015
    Report Date
    May 4, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT SHE HAD AN UNEXPECTED RESTART AND A BUTTON ERROR ALARM. CUSTOMER'S BLOOD GLUCOSE WAS 398 MG/DL TODAY. CUSTOMER STATED THAT A TEMP BASAL WAS NOT PROGRAMMED BEFORE THE UNEXPECTED RESTART. CUSTOMER STATED THAT THE PUMP WAS STORED OR NOT IN USE FOR AN EXTENDED PERIOD OF TIME. CUSTOMER STATED THAT SHE DID NOT TAKE THE BATTERY OUT OF THE PUMP AND THAT SHE WAS OFF THE PUMP ON SUNDAY. CUSTOMER ALSO HAD A DISPLAYABLE HISTORY CHECK FAILED ON STARTUP AND EXTERNAL RAM ERROR ALARM IN THE ALARM HISTORY. CUSTOMER PERFORMED A SELF TEST AND THE PUMP PASSED. CUSTOMER STATED THAT THE PUMP WAS AGAINST HER BODY WHILE SHE WORKING AND WAS EXPOSED TO SWEAT. CUSTOMER STATED THAT THE NUMBER KEEPS GOING UP AND WILL NOT STOP. CUSTOMER COULD NOT USE THE BUTTONS ON THE PUMP. THE BUTTON ERROR ALARM IS NOT PRESENT IN THE HISTORY AT OR AROUND THE TIME THAT THE PUMP WAS EXPOSED TO MOISTURE. CUSTOMER WILL MONITOR THE PUMP AND STATED THAT IT LOOKS LIKE THE PUMP IS WORKING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337037 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR