BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4112237 · Received September 23, 2014

    Report

    Report Number
    3004209178-2014-94831
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 10, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP RECEIVED WITH CRACKED DISPLAY WINDOW, CRACKED DISPLAY WINDOW CORNER, BROCKEN RESERVOIR TUBE LIP AND CRACKED RESERVOIR TUBE.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 INSULIN PUMP HAS A CRACK ON THE RIGHT SITE CORNER OF THE SCREEN. CUSTOMER IS NOT AWARE OF HOW THE DAMAGE OCCURRED. BLOOD GLUCOSE VALUE IS 9.2 MMOL/L. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592467 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-554CAP

    Patients

    Seq Age Sex Outcome Treatment
    1