BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4014230 · Received August 18, 2014

    Report

    Report Number
    3004209178-2014-94024
    Event Type
    Malfunction
    Date Received
    August 18, 2014
    Date of Event
    July 11, 2014
    Report Date
    July 11, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    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

    CUSTOMER REPORTED MOTOR ERROR ALARM HAD OCCURRED DURING A BOLUS. CUSTOMER'S BLOOD GLUCOSE WAS 290 MG/DL. CUSTOMER COULD NOT RECALL ANY SIGNIFICANT EVENTS LEADING TO THE ALARM. THE CUSTOMER WAS ADVISED TO DISCONNECT FROM THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492979 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR