BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4509472 · Received February 11, 2015

    Report

    Report Number
    2032227-2015-06286
    Event Type
    Malfunction
    Date Received
    February 11, 2015
    Date of Event
    January 28, 2015
    Report Date
    January 28, 2015
    Manufacturer
    MEDTRONIC MINIMED
    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

    THE INSULIN PUMP WAS RECEIVED WITH HIGH IDLE CURRENT DUE TO MOISTURE DAMAGE FOUND ON INTERFACE BOARD. THE DEVICE HAD MINOR SCRATCHED LCD WINDOW 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 ON (B)(6) 2014, THE INSULIN PUMP HAD A LOW BATTERY LIFE. CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102694 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-554LWWL

    Patients

    Seq Age Sex Outcome Treatment
    1