BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3870759 · Received June 12, 2014

    Report

    Report Number
    3004209178-2014-85615
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 21, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    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

    IT WAS REPORTED THAT THE INSULIN PUMP IS NOT WORKING CORRECTLY. CUSTOMER IS EXPERIENCING HIGH BLOOD GLUCOSE. THE BLOOD GLUCOSE LEVELS WILL NOT GO DOWN. THE CURRENT BLOOD GLUCOSE READING IS 212 MG/DL. THE INSULIN PUMP IS UNDER-DELIVERING INSULIN. CUSTOMER CONTINUES TO REPEAT THE BOLUSES AND THE BLOOD GLUCOSE LEVELS WILL NOT DECREASE. DURING TROUBLESHOOTING, THE PROGRAMMING IS CORRECT. NOTHING FURTHER REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347350 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR