BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4988343 · Received August 10, 2015

    Report

    Report Number
    2032227-2015-26165
    Event Type
    Malfunction
    Date Received
    August 10, 2015
    Date of Event
    July 16, 2015
    Report Date
    July 16, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT ALARMED BUTTON ERROR FOLLOWED BY INTERMITTENT BUTTONS DUE TO CORRODED LCD BOARD. NO TRACES OF MOISTURE FOUND AT MOTHER BOARD, INTERFACE BOARD, RF BOARD, OR KEYPAD ASSEMBLY PER VISUAL INSPECTION. UNIT RECEIVED WITH CRACKED CASE AT DISPLAY WINDOW CORNERS AND MINOR SCRATCHED LCD WINDOW. THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4) SITE, PER VARIANCE 5.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS EXPOSED TO WATER. HE JUMPED INTO A HOT TUB WITH THE INSULIN PUMP ON. THE INSULIN PUMP ALARMED BUTTON ERROR. FLUID WAS UNDER THE LCD DISPLAY. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 290 MG/DL. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACKUP PLAN. THE CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED AND AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522024 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR