BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3942699 · Received July 17, 2014

    Report

    Report Number
    2032227-2014-04227
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 14, 2014
    Report Date
    June 17, 2014
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM
    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 AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT SHE HAD MOISTURE ON HER INSULIN PUMP DUE TO A RESERVOIR LEAK. TROUBLESHOOTING WAS PERFORMED FOR THE DEVICE, CUSTOMER DECLINED HIGH BLOOD GLUCOSE. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 375 MG/DL. FLUID IS LOCATED IN THE RESERVOIR COMPARTMENT. FLUIDS OCCURRED DUE TO CUSTOMER PULLING OUT THE PLUNGER OF THE RESERVOIR ALONG WITH O-RINGS. CUSTOMER WAS ADVISED TO DISCONNECT FROM THE DEVICE AND REMOVE RESERVOIR. NO CURRENT LEAK NOTED. NO CRACKS OR DAMAGE NOTED. SELF TEST COMPLETED. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418452 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MMT-523RNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR