BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3981705 · Received August 5, 2014

    Report

    Report Number
    2032227-2014-06012
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 4, 2014
    Report Date
    July 4, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO AN INFECTION. CUSTOMER WAS ALSO EXPERIENCING LOW BLOOD GLUCOSE READINGS AND BELIEVES THAT THE INSULIN PUMP MAY BE OVER DELIVERING. TROUBLESHOOTING WAS PERFORMED AND THE DRIVE SUPPORT CAP AND ALL SETTINGS APPEARED TO BE NORMAL. CUSTOMER THEN STATED THAT THEY MADE CHANGES TO THEIR SENSITIVITY SETTINGS AND THE BLOOD GLUCOSE READINGS ARE NOW FINE. CUSTOMER'S CURRENT BLOOD GLUCOSE READING IS 199 MG/DL. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457448 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization