BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3900894 · Received June 27, 2014

    Report

    Report Number
    2032227-2014-03401
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    April 22, 2014
    Report Date
    June 6, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP FAILED THE DISPLACEMENT TEST WITH UNITS REMAINING ON THE STATUS SCREEN. UNIT HAD MOTOR ERROR ALARMS DURING REWIND DUE TO MOTOR ENCODER SIGNAL OUT OF PHASE. UNIT HAD CRACKED CASE AT DISPLAY WINDOW CORNERS AND BATTERY TUBE THREADS, SCRATCHED DISPLAY WINDOW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S INSULIN PUMP WAS ALARMING MOTOR ERROR AND CUSTOMER WAS UNABLE TO CLEAR IT. CALLER STATED THAT THE CUSTOMER HAD AN MRI ON THE KNEE AND THE INSULIN PUMP WAS EXPOSED TO A MAGNETIC FIELD. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377067 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-754LCMS

    Patients

    Seq Age Sex Outcome Treatment
    1