BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 5981372 · Received September 27, 2016

    Report

    Report Number
    2032227-2016-21965
    Event Type
    Malfunction
    Date Received
    September 27, 2016
    Date of Event
    November 14, 2013
    Report Date
    November 14, 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

    FAILURE ANALYSIS NOTED THAT THE PUMP ALARMED MOTOR ERROR DURING REWIND AND MOTOR POSITION ENCODER ERROR CONFIRMED IN THE HISTORY FILE DUE TO MOTOR ENCODER SIGNAL OUT OF PHASE. THEY WERE UNABLE TO PERFORM THE DISPLACEMENT TEST DUE TO THE MOTOR ERROR ALARM. THE PUMP HAD SCRATCHED LCD WINDOW, BROKEN BELT CLIP SLOT AT BATTERY TUBE THREADS AREA AND CRACKED RESERVOIR TUBE LIP. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE PUMP HAD MOTOR ERROR ALARM AND MOTOR POSITION ENCODER ERROR ALARM. THE BLOOD GLUCOSE AT THE TIME OF THE INCIDENT WAS 103 MG/DL. TROUBLESHOOTING WAS NOT ABLE TO RESOLVE THE ISSUE. THE DEVICE WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632747 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR