BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2863205 · Received December 10, 2012

    Report

    Report Number
    3004209178-2012-91170
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    September 23, 2012
    Report Date
    October 26, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP HAD A FROZEN DISPLAY AND CONSTANT TONE AS A RESULT OF A FAULTY COMPONENT ON THE INTERFACE BOARD. UNABLE TO CONFIRM THE ALARM OR THE BLANK DISPLAY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP ALARMED, AND SHE WAS NOT ABLE TO CLEAR THE ALARM. THE CALLER REMOVED THE BATTERY FOR FIVE MINUTES, BUT THE DISPLAY DID NOT RETURN. INSTRUCTED THE CUSTOMER TO REMOVE THE BATTERY FOR TWO HOURS, BUT THE DEVICE TURNED OFF AGAIN SEVERAL TIMES AFTER THE INSULIN PUMP WAS RESET. ADVISED THE CUSTOMER THAT THE INSULIN PUMP 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
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR