BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3930512 · Received July 12, 2014

    Report

    Report Number
    3004209178-2014-86723
    Event Type
    Malfunction
    Date Received
    July 12, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    NO BUTTON ERROR ALARM NOTED. NO BUTTON RESPONSE DUE TO FLATTENED ACT BUTTON DOME SWITCH. MINOR SCRATCHED LCD WINDOW, CRACKED DISPLAY WINDOW CORNERS, BATTERY TUBE THREADS AND CRACKED RESERVOIR TUBE LIP NOTED. UNABLE TO PERFORM THE DISPLACEMENT TEST DUE TO KEYPAD ANOMALY.

    Description of Event or Problem · 1

    CUSTOMER CALLED BECAUSE HER INSULIN PUMP WAS ALARMING BUTTON ERROR WHILE SHE WAS AT WORK. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 160 MG/DL. THERE WERE NO SIGNIFICANT EVENTS LEADING UP TO THE ALARM. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACK UP PLAN. THE DEVICE WILL NEED TO BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408902 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR