BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4223152 · Received November 4, 2014

    Report

    Report Number
    2032227-2014-47175
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 3, 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

    UNIT RECEIVED WITH SEVERELY CRACKED AND BLEEDING LCD GLASS, MISSING DISPLAY WINDOW, BROKEN OFF END CAP, CRACKED LCD WINDOW CORNERS, CRACKED RESERVOIR TUBE LIP, AND SCRATCHED AROUND CASING. UNABLE TO CONFIRM MISSING SEGMENTS OR PARTIAL DISPLAY DUE TO CRACKED AND BLEEDING LCD GLASS. (B)(4). 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'S INSULIN PUMP'S CASE WAS BROKEN NEAR THE BATTERY COMPARTMENT. THE LCD SCREEN, THE BATTERY END CAP, AND THE BATTERY COMPARTMENT THREADS WERE BROKEN. THE PUMP WAS RUN OVER BY A BUS. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS NOT REPORTED. THE PRODUCT WAS RETURNED. NOTHING FURTHER TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705963 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-754WWS

    Patients

    Seq Age Sex Outcome Treatment
    1