BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3945870 · Received July 21, 2014

    Report

    Report Number
    3004209178-2014-87971
    Event Type
    Malfunction
    Date Received
    July 21, 2014
    Date of Event
    June 19, 2014
    Report Date
    June 19, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    OTHER

    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 HIGH BLOOD GLUCOSE READINGS AND STATED THAT THE ISSUE MAY BE RELATED TO THE SETTINGS. CUSTOMER'S CURRENT BLOOD GLUCOSE READING IS 434 MG/DL AND HAS TREATED WITH THE INSULIN PUMP. TROUBLESHOOTING WAS PERFORMED AND AIR BUBBLES WERE NOTED IN THE TUBING. IT WAS ALSO NOTED THAT THE CUSTOMER DID NOT SUSPEND THE PUMPS DELIVERY AND INSERTED THE RESERVOIR WITHOUT REWINDING AND PRIMING. ALL SETTINGS AND THE DRIVE SUPPORT CAP APPEARED TO BE NORMAL. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426096 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR