BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4942686 · Received July 27, 2015

    Report

    Report Number
    3004209178-2015-77975
    Event Type
    Malfunction
    Date Received
    July 27, 2015
    Date of Event
    April 1, 2015
    Report Date
    July 6, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP RECEIVED WITH INTERMITTENT ESC, ACT, UP ARROW, AND DOWN ARROW BUTTON RESPONSE DUE TO FLATTENED BUTTON DOME SWITCHES. INSULIN PUMP PASSED THE DISPLACEMENT, PRIME AND EXCESSIVE NO DELIVERY TEST. NO EXCESSIVE NO DELIVERY ALARM NOTED. INSULIN PUMP RECEIVED WITH MINOR SCRATCHED LCD WINDOW AND SCRATCHED RESERVOIR TUBE WINDOW.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA PHONE CALL, THAT THE BUTTONS ON THE INSULIN PUMP ARE UNRESPONSIVE. IT WAS ALSO REPORTED THAT THE CUSTOMER HAD A NO DELIVERY ALARM. CUSTOMER'S BLOOD GLUCOSE LEVEL AT THE TIME WAS UNKNOWN. TROUBLESHOOTING OCCURRED. ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP, AND REVERT TO A BACK-UP PLAN. THE CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED AND AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487513 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523RNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR