BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4791016 · Received May 22, 2015

    Report

    Report Number
    3004209178-2015-58788
    Event Type
    Malfunction
    Date Received
    May 22, 2015
    Date of Event
    May 3, 2015
    Report Date
    May 3, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    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 THAT THE INSULIN PUMP WAS MISSING HISTORY. THE CUSTOMER STATES THE INSULIN PUMP IS WORKING FINE, BUT SHOWS NO BOLUS HISTORY. THE INSULIN PUMP WAS TEST BY DELIVERING A BOLUS AND THE INSULIN PUMP REGISTERED THE BLOUSE. ALSO THE CUSTOMER MENTIONED THAT HE IS VISUALLY IMPAIRED. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 312 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336195 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 69 YR