BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 6125690 · Received November 23, 2016

    Report

    Report Number
    2032227-2016-44021
    Event Type
    Malfunction
    Date Received
    November 23, 2016
    Date of Event
    October 22, 2016
    Report Date
    October 29, 2016
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT
    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

    CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A BLANK DISPLAY ANOMALY. THE PATIENT'S BLOOD GLUCOSE AT THE TIME OF INCIDENT WAS 388 MG/DL. TROUBLESHOOTING WAS INITIATED FOR THE BLANK DISPLAY. THE CUSTOMER CONFIRMED THAT THE INSULIN PUMP WAS NOT BUMPED, DROPPED, OR EXPOSED TO MOISTURE. THE CUSTOMER ALSO CONFIRMED THAT THE BATTERY CAP CONTACTS, BATTERY COMPARTMENT, AND SPRING DID NOT HAVE ANY DAMAGE, CORROSION, OR MISSING COMPONENTS. A NEW ALKALINE AAA BATTERY WAS INSERTED INTO THE INSULIN PUMP BUT THE DISPLAY DID NOT RETURN. THE BATTERY CAP CONTACT WAS CLEANED AND A NEW AAA ALKALINE BATTERY WAS INSERTED AGAIN AND THE DISPLAY RETURNED; HOWEVER, THE INSULIN PUMP ALARMED FAILED BATTERY TEST. THE ALARM WAS CLEARED. THE INSULIN PUMP WAS NOT RETURNED FOR ANALYSIS AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776102 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR