BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4183470 · Received October 18, 2014

    Report

    Report Number
    2032227-2014-40222
    Event Type
    Malfunction
    Date Received
    October 18, 2014
    Date of Event
    September 20, 2014
    Report Date
    September 20, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    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. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP RECEIVED WITH BLANK DISPLAY DUE TO CORROSION IN BATTERY TUBE AND MOISTURE DAMAGE ON LCD BOARD. UNABLE TO VERIFY OPERATING CURRENTS DUE TO FAILED BATTERY TEST. THE INSULIN PUMP HAS MINOR SCRATCHES ON LCD WINDOW, CRACKED BATTERY TUBE THREADS, STAINED ADDRESS SERIAL NUMBER LABEL AND STAINED END CAP STICKER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD HIGH BLOOD GLUCOSE LEVELS OF 205 MG/DL. THE CUSTOMER REPORTED A FAILED BATTERY TEST ON THE INSULIN PUMP AND THEREAFTER A BLANK DISPLAY OCCURRED. THE CUSTOMER REPORTED THAT THE INSULIN PUMP WAS EXPOSED TO MOISTURE FROM A BIT OF WATER DURING AN AIRPLANE TRIP. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WOULD NEED TO BE REPLACED. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO A BACK-UP PLAN PER THE HEALTH CARE PROVIDER'S INSTRUCTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664024 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR