BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3971920 · Received July 31, 2014

    Report

    Report Number
    3004209178-2014-88588
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 2, 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
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FROZEN SCREEN DUE TO MOISTURE DAMAGE ON THE ELECTRONICS. MOISTURE DAMAGE FOUND ON THE MOTOR ALSO. UNABLE TO VERIFY THE ACTIVATION ANOMALY DUE TO FROZEN SCREEN. NO HIGH BEEP OR AUDIO BEEP ANOMALY NOTED. PUMP RECEIVED WITH CRACKED DISPLAY WINDOW CORNER, RESERVOIR TUBE LIP, SCRATCHED LCD WINDOW.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT WHEN INSERTING A NEW BATTERY, THE PUMP GIVES A HIGH BEEP. THE BLOOD GLUCOSE READING IS 18 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446952 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-754LWWL

    Patients

    Seq Age Sex Outcome Treatment
    1