BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3920047 · Received July 8, 2014

    Report

    Report Number
    3004209178-2014-86496
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV
    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

    INSULIN PUMP RECEIVED WITH DOWN ARROW BUTTON NOT RESPONDING DUE TO A FLATTENED BUTTON DOME SWITCH. NO FROZEN SCREEN NOTED. INSULIN PUMP RECEIVED WITH CRACKED DISPLAY WINDOW, CRACKED DISPLAY WINDOW CORNERS, CRACKED BATTERY TUBE THREADS, CRACKED RESERVOIR TUBE LIP. NO INSULIN SMELL ON INSULIN PIMP NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THE INSULIN PUMP'S DISPLAY SCREEN HAS NUMEROUS CHIPS AND SCRATCHES. CUSTOMER STATED DAMAGE MAY HAVE OCCURRED FROM FALLING A LOT. CUSTOMER ALSO STATED THAT THEY TRIED TO ATTACH THE INFUSION SET BUT THE DISPLAY SCREEN WAS FROZEN AND IS UNABLE TO INPUT COMMANDS. ALTHOUGH THE CUSTOMER STATED HOSPITALIZATION WHILE REPORTING MALFUNCTION, IT WAS UNRELATED TO THE DEVICE AS THE CUSTOMER WAS TRYING TO GET APPROVED FOR BACK SURGERY, WHICH WAS COMPLETED PRIOR TO REPORTING. ADVISED CUSTOMER TO DISCONTINUE USE OF DEVICE AND REVERT TO HEALTHCARE PROVIDER'S INSTRUCTIONS. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 230 MG/DL AT TIME OF REPORTING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396738 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR