BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4123487 · Received September 26, 2014

    Report

    Report Number
    2032227-2014-29705
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 28, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    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

    THE CUSTOMER REPORTED THAT THE DISPLAY ON THE INSULIN PUMP WAS BLANK. THE CUSTOMER STATED HE SHUT OFF THE PUMP FOR THREE DAYS. THE CUSTOMER ALSO STATED THAT THE CONTACTS ON THE BATTERY CAP WERE NOT MISSING OR DAMAGED AND NEITHER THE BATTERY COMPARTMENT NOR SPRING WERE DAMAGED OR CORRODED. THE CUSTOMER INSERTED A NEW BATTERY AND THE DISPLAY RETURNED. THE CUSTOMER CLEANED THE BATTERY CAP, ALLOWED IT TO DRY AND INSERTED THE BATTERY. THE DISPLAY RETURNED. A SELF-TEST WAS RUN AND PASSED. THE CUSTOMER'S BLOOD GLUCOSE WAS NOT KNOWN. THERE WAS A NO DELIVERY ALARM IN THE ALARM HISTORY AND THE CUSTOMER REPORTED IT WAS RESOLVED WITH A RESERVOIR CHANGE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600101 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR