BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3984526 · Received August 6, 2014

    Report

    Report Number
    3004209178-2014-90356
    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
    IA
    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 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

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED MOTOR ERROR AND THE KEYS OF THE DEVICE WERE LOCKED UP. THE CUSTOMER'S BLOOD GLUCOSE WAS 486 MG/DL, WHICH WAS TREATED WITH THE INSULIN PUMP WHILE IT WAS STILL WORKING. TROUBLESHOOTING WAS PERFORMED AND THE DEVICE STARTED FUNCTIONING NORMALLY, BUT THEN THE DEVICE ALARMED FILED BATTERY TEST. THE CUSTOMER CALLED BACK LATER, THE SAME DAY, AND STATED THAT THEY PLACED BRAND A NEW BATTERY INTO THE INSULIN PUMP AND THE DEVICE WAS BACK UP AND RUNNING. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460441 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 55 YR