BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4233541 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-48868
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 9, 2014
    Report Date
    October 9, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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 THE CUSTOMER COULD NOT EXIT THE REWIND COMPLETE SCREEN. THE CUSTOMER STATED THEIR INSULIN COULD NOT BE PROCESSED BECAUSE THEY WERE STUCK IN THE REWIND COMPLETE/BOLUS DELIVERY LOOP. TROUBLESHOOTING WAS ABLE TO RESOLVE THE ISSUE. THE CUSTOMER WAS ADVISED THAT THE ISSUE WAS CAUSED BY THE CUSTOMER'S ATTEMPT TO BOLUS DURING THE REWIND/FILL TUBING PROCESS. THE CUSTOMER WAS ALSO ASSISTED WITH SUCCESSFULLY DELIVERING THEIR BOLUS. CUSTOMER'S BLOOD GLUCOSE 246 MG/DL. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715241 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR