BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3822227 · Received May 20, 2014

    Report

    Report Number
    3004209178-2014-84838
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 17, 2014
    Report Date
    May 8, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP FAILED THE DISPLACEMENT TEST FOLLOWED BY A MOTOR ERROR ALARM DURING THE REWIND AS A RESULT OF A MOTOR ENCODER SIGNAL BEING OUT OF PHASE. THE DEVICE WAS RECEIVED WITH CRACKED CASE AT THE DISPLAY WINDOW CORNERS, AND RESERVOIR TUBE LIP AS WELL SCRATCHED SCREEN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HAVING AN MRI AND THE INSULIN PUMP WAS NEAR THE DOOR WAY OF THE ROOM. THE BLOOD GLUCOSE READING WAS 250MG/DL. 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
    300680 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR