BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4223308 · Received November 4, 2014

    Report

    Report Number
    2032227-2014-46753
    Event Type
    Injury
    Date Received
    November 4, 2014
    Date of Event
    October 5, 2014
    Report Date
    October 5, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED SHE WAS UNABLE TO COMPLETE AN INFUSION SET CHANGE WHILE TROUBLESHOOTING FOR A NO DELIVERY ALARM. THE CUSTOMER ALSO REPORTED RECEIVING A FAILED BATTERY TEST ALARM. CUSTOMER'S BLOOD GLUCOSE WAS 125 MG/DL. THE CUSTOMER STATED HER BATTERY COMPARTMENT WAS NOT DAMAGED OR CORRODED. TROUBLESHOOTING WAS ABLE TO RESOLVE THE FAILED BATTERY TEST ALARM. CUSTOMER WAS ADVISED TO MONITOR THE ISSUE. CUSTOMER ALSO STATED THEY WERE HOSPITALIZED FOR URINARY TRACT INFECTIONS. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706442 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization