BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3934386 · Received July 15, 2014

    Report

    Report Number
    2032227-2014-03912
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    June 15, 2014
    Report Date
    June 15, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    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

    SENSOR IS ALARMING LOST SENSOR. THE BLOOD GLUCOSE READING IS 166 MG/DL. THE LOST SENSOR OCCURRED WITH A PREVIOUS SENSOR. CUSTOMER ADVISED THAT ENLITE SENSOR AND REVEL INSULIN PUMP IS OFF LABEL USE. DURING TROUBLESHOOTING, CUSTOMER MOVED THE IPAD AND RECEIVED A SIGNAL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412107 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR