BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4183564 · Received October 18, 2014

    Report

    Report Number
    2032227-2014-40354
    Event Type
    Malfunction
    Date Received
    October 18, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 19, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK
    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 IS REPORTED THAT A CUSTOMER STATES THAT THE SCREEN OF THEIR INSULIN PUMP GOES BLACK AFTER CHANGING THE BATTERY. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS NOT RECORDED. THE CUSTOMER WAS ADVISED TO TURN OFF HIS TEMPO BASAL BEFORE CHANGING BATTERY THEN RESTART THE TEMPORARY BASAL WHEN DONE WITH BATTERY CHANGE. THE CUSTOMER WAS THEN ADVISED TO MONITOR THE PUMP FOR ANY FURTHER ISSUES. NO FURTHER ASSISTANCE NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663959 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR