BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3112526 · Received May 14, 2013

    Report

    Report Number
    2032227-2013-01936
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    May 3, 2013
    Report Date
    May 3, 2013
    Manufacturer
    MEDTRONIC MINIMED
    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

    THE INSULIN PUMP HAD A FROZEN DISPLAY WITH A CONSTANT TONE DUE TO MOISTURE DAMAGE ON THE LCD AND MOTHER BOARD. UNABLE TO CONFIRM THE MOTOR ERROR ALARMS DUE TO THE FROZEN DISPLAY. MOISTURE DAMAGE WAS NOTED ON THE MOTOR ASSEMBLY. NO BLANK DISPLAY WAS NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP GAVE A MOTOR ERROR ALARM FOLLOWED BY A BLANK DISPLAY. IT WAS STATED THAT THIS CONTINUED HAPPENING IN A LOOP, AND THE INSULIN PUMP WOULD NOT GET OUT OF IT. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212347 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522LCAS

    Patients

    Seq Age Sex Outcome Treatment
    1