BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3972047 · Received July 31, 2014

    Report

    Report Number
    2032227-2014-05049
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    May 6, 2014
    Report Date
    July 2, 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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED MULTIPLE ALARMS ON HER INSULIN PUMP, INCLUDING A MOTOR ERROR ALARM. THE CUSTOMER'S BLOOD GLUCOSE WAS 7.9 MMOL/L. SHE WAS UNABLE TO REWIND THE PUMP AS THE REWIND WAS INTERRUPTED BY THE MOTOR ERROR ALARM. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE PUMP AND TO REVERT TO A BACK-UP PLAN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447370 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-554LCMS

    Patients

    Seq Age Sex Outcome Treatment
    1