BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4771249 · Received May 14, 2015

    Report

    Report Number
    3004209178-2015-56191
    Event Type
    Malfunction
    Date Received
    May 14, 2015
    Date of Event
    December 31, 2014
    Report Date
    April 23, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    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 VIA PHONE CALL INDICATING THAT THE INSULIN PUMP ALARMS LOW BATTERY, WEAK BATTERY AND FAILED BATTERY TEST. CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN. AFTER TROUBLESHOOTING WAS DONE, THE CUSTOMER WAS ADVISED THAT WE WOULD SEND REPLACEMENT BATTERY CAP. CUSTOMER WAS ADVISED TO MONITOR WHEN CHANGING BATTERY AND CALL IF THERE ARE ANY ISSUES WITH IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315313 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR