BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4850757 · Received June 17, 2015

    Report

    Report Number
    3004209178-2015-65705
    Event Type
    Malfunction
    Date Received
    June 17, 2015
    Date of Event
    December 19, 2014
    Report Date
    December 19, 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

    UNIT ALARMED MOTOR ERROR DURING BASIC OCCLUSION TEST DUE TO FAULTY BACK PRESSURE SENSOR. THE MOTOR WAS TESTED OUTSIDE THE DEVICE AND PASSED. PUMP RECEIVED WITH MINOR SCRATCHED LCD WINDOW, SCRATCHED RESERVOIR TUBE WINDOW AND CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A MOTOR ERROR ALARM DURING THE FILL CANNULA STAGE. THE CUSTOMER REPORTED THAT THE INSULIN PUMP ALSO HAD A MOTOR POSITION ENCODER ERROR. CUSTOMER DID NOT RECALL ANY SIGNIFICANT EVENTS LEADING UP TO THE ERROR ALARM. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 179 MG/DL. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WOULD BE REPLACED AND AGREED TO RETURN THE DEVICE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394100 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR