BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3982224 · Received August 5, 2014

    Report

    Report Number
    3004209178-2014-90144
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 5, 2014
    Report Date
    July 5, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    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

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS RECEIVED WITH BUTTON ERROR ALARM AND THE BUTTONS WERE NOT RESPONDING DUE TO CORRODED KEYPAD TRACES. UNABLE TO PERFORM THE DISPLACEMENT TEST DUE TO THE UNRESPONSIVE BUTTONS. THE DEVICE ALSO WAS RECEIVED WITH NO MOISTURE DAMAGE ON THE ELECTRONICS, MOTOR, VIBRATOR MOTOR OR BATTERY TUBE ASSEMBLY. THE UNIT HAD CRACKED CASE AT THE DISPLAY WINDOW CORNER, CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHED LCD WINDOW AND BROKEN BATTERY TUBE THREADS.

    Description of Event or Problem · 1

    CUSTOMER CALLED STATING SHE WAS ON A BOAT AND HER INSULIN PUMP GOT WET. THE DEVICE ALARMED BUTTON ERROR. CUSTOMER'S BLOOD GLUCOSE IS 86 MG/DL. 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
    456907 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR