BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4191012 · Received October 21, 2014

    Report

    Report Number
    2032227-2014-41228
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    May 15, 2014
    Report Date
    September 22, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV
    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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. THE INSULIN PUMP PASSED DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME/A33AND EXCESSIVE NO DELIVERY TESTS. NO UNEXPECTED EXCESSIVE NO DELIVERY ALARM NOTED. THE INSULIN PUMP HAS CRACKED CASE AT THE DISPLAY WINDOW CORNER, CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHED LCD WINDOW, MISSING END CAP STICKER AND CRACKED BATTERY TUBE THREADS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BUTTONS ON THE INSULIN PUMP ARE STICKING. IT WAS ALSO REPORTED THAT VIBRATION ON THE INSULIN PUMP IS VERY LOW. ADVISED INSULIN PUMP WOULD BE REPLACED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669914 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR