BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4190921 · Received October 21, 2014

    Report

    Report Number
    2032227-2014-41176
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 22, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP HAD AN INTERMITTENT BUTTON RESPONSE DUE TO CORRODED ACT AND UP BUTTON ON KEYPAD TRACES. NO CONSTANT TONE NOTED. NO MOISTURE DAMAGE ON ELECTRONIC, MOTOR, VIBRATOR AND BATTERY TUBE ASSEMBLY DURING VISUAL INSPECTION. INSULIN PUMP HAD MINOR SCRATCHES ON LCD WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNERS, CRACKED RESERVOIR TUBE LIP AND STAINED END CAP STICKER.

    Additional Manufacturer Narrative · 1

    (B)(4).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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT HE WENT SWIMMING INTO THE POOL AND THE OCEAN WITH THE INSULIN PUMP IN HIS POCKET. CUSTOMER STATED THE INSULIN PUMP HAD A HIGH PITCHED BEEP SO HE REMOVED THE BATTERY AND HASN'T USED THE DEVICE FOR ABOUT A WEEK. CUSTOMER REPORTED THE INSULIN PUMP WAS EXPOSED TO FLUID IN THE PAST WITH NO MOISTURE VISIBLE. CUSTOMER STATED THE BUTTONS ARE NOT RESPONDING. BLOOD GLUCOSE VALUE IS 107 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669834 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAL B1723NALJ

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR