BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4000310 · Received August 11, 2014

    Report

    Report Number
    3004209178-2014-90219
    Event Type
    Malfunction
    Date Received
    August 11, 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
    MA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP RECEIVED WITH INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARM NOTED. INSULIN PUMP RECEIVED WITH CRACKED CASE ON DISPLAY WINDOW CORNERS AND CRACKED RESERVOIR TUBE LIP.

    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 IS REPORTED THAT THE CUSTOMER HAD HIGH BLOOD GLUCOSE LEVELS OF 160 MG/DL. THE CUSTOMER REPORTED A BUTTON ERROR ALARM FROM THE INSULIN PUMP. THE CUSTOMER REPORTED THAT THE INSULIN PUMP HAD COME INTO CONTACT WITH WATER. THE CUSTOMER WAS ADVISED TO DISCONTINUE THE USE OF THE INSULIN PUMP AND TO REVERT TO A BACK-UP PLAN PER THE HEALTH CARE PROVIDER'S INSTRUCTION. NO ADDITIONAL INFORMATION IS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476329 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR