BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2761172 · Received September 26, 2012

    Report

    Report Number
    3004209178-2012-89700
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Date of Event
    August 12, 2012
    Report Date
    September 14, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS RECEIVED WITH FROZEN DISPLAY DUE TO MOISTURE DAMAGE FOUND ALSO ON THE MOTOR. FURTHER TESTING COULD NOT BE PERFORMED DUE TO THE FROZEN DISPLAY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HAVING A BUTTON ERROR ALARM. TROUBLESHOOTING WAS PERFORMED. THE BUTTONS WERE NOT PRESSED DOWN FOR THREE MINUTES OR GREATER. THE BLOOD GLUCOSE READING WAS 267MG/DL. THE CALLER MENTIONED ALSO GETTING BATTERY ALARMS AND UNRESPONSIVE BUTTONS. ADVISED THE CUSTOMER THAT THE INSULIN PUMP IS REPLACED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR