BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4131853 · Received October 1, 2014

    Report

    Report Number
    2032227-2014-31497
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO UNEXPECTED BUTTON ERROR ALARMS NOTED. UNABLE TO PERFORM DISPLACEMENT TEST DUE TO NO BUTTON RESPONSE ON THE ACT AND DOWN ARROW BUTTONS. INSULIN PUMP KEYPAD WAS UNRESPONSIVE DUE TO CORRODED KEYPAD TRACES NOTED. INSULIN PUMP HAD MINOR SCRATCHES ON LCD WINDOW, CRACKED CASE AT LCD WINDOW CORNER, CRACKED RESERVOIR TUBE LIP, SCRATCHES ON RESERVOIR TUBE WINDOW, CRACKED RESERVOIR TUBE, CRACKED BATTERY TUBE THREADS, CRACKED BELT CLIP SLOT AND STAINED END CAP STICKER.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD A BUTTON ERROR ALARM ON THE INSULIN PUMP. CUSTOMER PRESSED THE ESC AND ACT BUTTONS AND IT WOULD NOT CLEAR THE ALARM. CUSTOMER THEN REMOVED THE BATTERY. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 70 MG/DL. CUSTOMER WAS AT THE BEACH AND SHE HAD HER FEET IN THE WATER, BUT PUMP WAS NOT SUBMERGED IN THE WATER. CUSTOMER THINKS THAT THE PUMP WAS EXPOSED TO SWEAT. INSULIN PUMP WILL NEED TO BE REPLACED. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612513 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR