BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3980979 · Received August 5, 2014

    Report

    Report Number
    3004209178-2014-89988
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    May 24, 2014
    Report Date
    July 3, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP WAS RECEIVED WITH NORMAL OPERATING CURRENTS AND NO UNEXPECTED OFF NO POWER, LOW BATTERY OR BATTERY OUT LIMIT ALARMS NOTED. DEVICE WAS MONITORED FOR 24 HRS AND NO UNEXPECTED ALARM CLOCK ALARM NOTED. DEVICE HAD INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. DEVICE RECEIVED WITH CRACKED DISPLAY WINDOW CORNER, SCRATCHED LCD WINDOW, BROKEN RESERVOIR TUBE LIP AND CRACKED RESERVOIR TUBE WINDOW.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE INSULIN PUMP HAS AN ALARM CLOCK AND HE IS UNABLE TO CLEAR IT. CUSTOMER STATED HE REPLACED THE BATTERY AND IT ALARMED BATTERY OUT LIMIT. CUSTOMER CHANGED THE BATTERY AGAIN AND THE ALARM MESSAGE DISPLAY WENT AWAY BUT DEVICE CONTINUES TO SIREN AND VIBRATE. CUSTOMER DOES NOT RECALL ANY EVENTS LEADING TO THE ALARM. BLOOD GLUCOSE LEVEL IS 104 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457140 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR