BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4032367 · Received August 25, 2014

    Report

    Report Number
    3004209178-2014-97137
    Event Type
    Malfunction
    Date Received
    August 25, 2014
    Date of Event
    July 23, 2014
    Report Date
    July 23, 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

    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.

    Additional Manufacturer Narrative · 1

    MOISTURE DAMAGE WAS FOUND ON THE DISPLAY BOARD, MOTHER BOARD AND ON THE MOTOR. NO BUZZING NOISE OR FROZEN DISPLAY WAS NOTED. THE INSULIN PUMP HAD A CRACKED RESERVOIR TUBE WINDOW, CRACKED BATTERY TUBE THREADS AND MINOR SCRATCHES ON THE DISPLAY WINDOW.

    Description of Event or Problem · 1

    CUSTOMER REPORTED GOING IN A SWIMMING POOL WITH HIS INSULIN PUMP. WHEN HE GOT OUT, THE DEVICE WAS LOCKED UP AND THE SCREEN WAS COUNTING UP. THERE IS FLUID UNDER THE LCD SCREEN AND THERE ARE SOME CRACKS BY THE RESERVOIR COMPARTMENT. CUSTOMER'S BLOOD GLUCOSE IS 67 MG/DL. HE TREATED WITH BREAKFAST AND FEELS FINE. CUSTOMER WAS ADVISED THE DEVICE NEEDS TO BE REPLACED, AND TO DISCONTINUE USE AND REVERT TO A BACK UP PLAN. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514439 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR