BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3972163 · Received July 31, 2014

    Report

    Report Number
    3004209178-2014-88633
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS MONITORED IN 50C OVEN FOR SEVERAL DAYS AND NO BLANK DISPLAY WAS NOTED. THE DEVICE WAS RECEIVED WITH NORMAL OPERATING CURRENTS, AND NO DAMAGE ON THE LCD ISOLATION TAPE NOTED. NO UNEXPECTED FAILED BATTERY TEST ALARM WAS NOTED. THE DEVICE WAS, HOWEVER, RECEIVED WITH MOISTURE DAMAGE ON THE MOTOR AND LCD GLASS. NO MOISTURE DAMAGE FOUND ON THE MOTHER BOARD, INTERFACE BOARD, RADIO FREQUENCY BOARD, BATTERY TUBE ASSEMBLY AND VIBRATOR ASSEMBLY DURING VISUAL INSPECTION. THE DEVICE WAS ALSO NOTED TO HAVE A CRACKED CASE AT THE DISPLAY WINDOW CORNER AND CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP WAS EXPOSED TO FLUID AND DID NOT FUNCTION PROPERLY. THE BLOOD GLUCOSE READING WAS 162 MG/DL. THE CUSTOMER OBSERVED SCREEN CLOUDINESS AND FLUID UNDER THE LCD DISPLAY DUE TO POOL EXPOSURE. SHE ALSO STATED THAT THE DEVICE'S SCREEN SOMETIMES WENT BLANK AND ALARMED FAILED BATTERY TEST. CONFIRMED THAT THE INSULIN PUMP HAD NOT BEEN DROPPED. NO CRACKS WERE OBSERVED. ADVISED DISCONTINUATION OF THE DEVICE. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447594 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR