BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3971944 · Received July 31, 2014

    Report

    Report Number
    3004209178-2014-88540
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 7, 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

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS. UNIT HAD MOISTURE DAMAGE ON ELECTRONICS. DEVICE WAS RECEIVED WITH SCRATCHED DISPLAY WINDOW, CRACKED DISPLAY WINDOW CORNER, CRACKED BATTERY TUBE THREADS 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 DEVICE HAD ALARMED MOTOR ERROR AND THE SMELL OF INSULIN WAS COMING FROM THE RESERVOIR COMPARTMENT. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS NOT PROVIDED AT TIME OF REPORTING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448371 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-754WWH

    Patients

    Seq Age Sex Outcome Treatment
    1