BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3150897 · Received June 6, 2013

    Report

    Report Number
    3004209178-2013-94484
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 20, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    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 BUTTON ERROR FOLLOWED BY AN INTERMITTENT BUTTONS DUE TO CORRODED KEYPAD TRACES. THE DEVICE WAS UNABLE TO PRIME DURING THE PRIME TEST AS A RESULT OF A LOOSE/FLUSH MOTOR SUPPORT DISK. THE INSULIN PUMP WAS RECEIVED WITH SCRATCHED DISPLAY WINDOW.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP ALARMED BUTTON ERROR. THE BLOOD GLUCOSE READING WAS 160MG/DL. ADVISED THE CALLER THAT THE DEVICE WOULD BE REPLACED AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250695 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR