BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3930450 · Received July 11, 2014

    Report

    Report Number
    2032227-2014-03559
    Event Type
    Malfunction
    Date Received
    July 11, 2014
    Date of Event
    May 20, 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
    NY
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP ALARMED MOTOR ERROR DURING REWIND AS A RESULT OF A MOTOR ENCODER SIGNAL BEING OUT OF PHASE. FURTHER TESTING COULD NOT BE PERFORMED DUE TO THE MOTOR ANOMALY. THE DEVICE WAS RECEIVED WITH CRACKED BATTERY TUBE THREADS AND SCRATCHED SCREEN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP WAS WORN WHILE HAVING AN MRI AND FORGOT TO TAKE IT OFF. THE BLOOD GLUCOSE READING WAS UNKNOWN AT TIME OF CALL. ADVISED THE CALLER TO DISCONTINUE THE USE OF THE DEVICE AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408113 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR