BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4180853 · Received August 2, 2014

    Report

    Report Number
    3004209178-2014-89287
    Event Type
    Malfunction
    Date Received
    August 2, 2014
    Date of Event
    March 24, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MOTOR ERROR ALARM OCCURED DURING REWIND DUE TO A CORRODED MOTOR HOME SWITCH. DISPLACEMENT TEST COULD NOT BE PERFORMED DUE TO MOTOR ERROR ALARM. THE INSULIN PUMP HAD A SCRATCHED DISPLAY WINDOW, A CRACKED DISPLAY WINDOW CORNER, AND CRACKED RESERVOIR TUBE LIP. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE PARADIGM REAL-TIME VEO INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED A MOTOR ERROR ALARM ON HIS OR HER INSULIN PUMP. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452827 PARADIGM REAL-TIME INSULIN INFUSION PUMP OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-754WWL

    Patients

    Seq Age Sex Outcome Treatment
    1