BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4033338 · Received August 25, 2014

    Report

    Report Number
    3004209178-2014-96913
    Event Type
    Malfunction
    Date Received
    August 25, 2014
    Date of Event
    July 22, 2014
    Report Date
    July 24, 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.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP ALARMED FOR A BUTTON ERROR AND HAD NO BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. NO MOISTURE DAMAGE WAS FOUND INSIDE OF THE INSULIN PUMP. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED DISPLAY WINDOW CORNER, BROKEN BATTERY TUBE THREADS, A CRACKED RESERVOIR TUBE, A CRACKED RESERVOIR TUBE LIP, AND MINOR SCRATCHES ON THE DISPLAY WINDOW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED AND BUTTON ERROR ALARM AND THE KEYPAD ON THE CUSTOMER'S INSULIN PUMP BECAME LOCKED UP AFTER SHE WORKED OUT FOR 45 MINUTES WITH THE PUMP CLOSE TO HER BODY. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO A BACK-UP PLAN. HER BLOOD GLUCOSE LEVEL WAS 200 MG/DL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511386 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR