BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3801217 · Received May 8, 2014

    Report

    Report Number
    3004209178-2014-84476
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    March 14, 2014
    Report Date
    April 23, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    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 REVEALED THAT THE INSULIN PUMP FAILED THE DISPLACEMENT TEST DURING REWIND, MOTOR ERROR AND OTHER ERROR ALARM FOUND IN THE ALARM HISTORY AS A RESULT OF A MOTOR ENCODER SIGNAL BEING OUT OF PHASE. THE DEVICE WAS RECEIVED WITH CRACKED RESERVOIR TUBE LIP AND SCRATCHED SCREEN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED GETTING AN ERROR ALARM AND THE DEVICE ASKED TO REPROGRAM. THE CALLER STATED THAT THE INSULIN PUMP WAS STUCK AT TIME AND DATE SET UP. THE CUSTOMER STATED THAT THE DEVICE WAS EXPOSED TO A HIGH MAGNETIC FIELD. 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
    279026 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR