BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4860608 · Received June 22, 2015

    Report

    Report Number
    3004209178-2015-67638
    Event Type
    Malfunction
    Date Received
    June 22, 2015
    Date of Event
    June 2, 2015
    Report Date
    June 3, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    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 INSULIN PUMP WAS GOING TO BE REPLACED DUE TO MOTOR ERROR BUT CUSTOMER WANTED TO TROUBLESHOOT FOR EXCESSIVE NO DELIVERY ALARM. CUSTOMER'S BLOOD GLUCOSE WAS 214 MG/DL. CUSTOMER REPORTED THAT INSULIN PUMP WAS NOT ALARMING WHEN RESERVOIR WAS EMPTY. CUSTOMER WAS NOT ABLE TO TROUBLESHOOT FOR NO DELIVERY DUE TO MOTOR ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402788 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR