BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3984552 · Received August 6, 2014

    Report

    Report Number
    3004209178-2014-90528
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    June 27, 2014
    Report Date
    July 6, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 WAS RECEIVED WITH BLANK DISPLAY DUE TO MOISTURE DAMAGE ON ELECTRONIC ASSEMBLY. THE INSULIN PUMP WAS UNABLE TO VERIFY BUTTON KEYPAD ANOMALY DUE TO BLANK DISPLAY. THE INSULIN PUMP HAD A CRACKED DISPLAY WINDOW CORNER AND CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THERE IS FLUID UNDER THE LCD DISPLAY. CUSTOMER STATES THAT DUE TO THE INSULIN PUMP BEING EXPOSED TO FLUID, THE KEYPAD IS HAVING ISSUES. THE BLOOD GLUCOSE READING IS 104 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459931 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR