BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3023964 · Received March 27, 2013

    Report

    Report Number
    2032227-2013-01168
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 13, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP GAVE A MOTOR ERROR ALARM DURING THE REWIND DUE TO AN OUT OF PHASE MOTOR ENCODER SIGNAL. UNABLE TO PERFORM THE DISPLACEMENT TEST DUE TO THE MOTOR ERROR ALARM. THE INSULIN PUMP HAD NORMAL OPERATING CURRENTS. NO OFF NO POWER, LOW BATTERY OR FAILED BATTERY TEST ALARMS WERE NOTED. THE DRIVE SUPPORT DISK WAS INSPECTED AND NO ANOMALY WAS NOTED.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED TO REPORT A FAILED BATTERY TEST ALARM DURING NORMAL USE. THE CUSTOMER ALSO STATED THAT SHE EXPOSED THE INSULIN PUMP TO AN MRI MACHINE TODAY. THE CUSTOMER STATED THAT SHE WALKED INTO THE ROOM, BUT THE MACHINE WAS NOT ON. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP FAILED THE DISPLACEMENT TEST. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126697 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR