BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4945709 · Received July 28, 2015

    Report

    Report Number
    2032227-2015-23691
    Event Type
    Malfunction
    Date Received
    July 28, 2015
    Date of Event
    December 29, 2014
    Report Date
    June 29, 2015
    Manufacturer
    MEDTRONIC MINIMED
    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

    INSULIN PUMP RECEIVED WITH INTERMITTENT BUTTON RESPONSE AND BUTTON ERROR ALARM DUE TO CORRODED KEYPAD TRACES. NO MOISTURE DAMAGE ON THE LCD BOARD, MOTHERBOARD, INTERFACE BOARD, RF BOARD, MOTOR, VIBRATOR, AND BATTERY TUBE ASSEMBLY DURING VISUAL INSPECTION. INSULIN PUMP WAS RECEIVED WITH CRACKED CASE AT THE DISPLAY WINDOW CORNER, BROKEN RESERVOIR TUBE LIP, MINOR SCRATCHED LCD WINDOW, CRACKED BATTERY TUBE THREADS, AND BROKEN BELT CLIP SLOT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP'S BATTERY COMPARTMENT AND SCREEN WERE CRACKED. HER BELT CLIP WAS ALSO BROKEN. THE CUSTOMER'S PUPPY BIT HER INSULIN PUMP. THE INSULIN PUMP WAS EXPOSED TO WATER AND THERE WAS FLUID UNDER THE LCD DISPLAY. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS NOT REPORTED. 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
    489264 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR