BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3933129 · Received July 14, 2014

    Report

    Report Number
    3004209178-2014-86921
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 14, 2014
    Report Date
    June 14, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    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

    IT WAS REPORTED THAT THE CUSTOMER HAD HIGH BLOOD GLUCOSE WHILE TRYING TO INSTALL A NEW RESERVOIR INTO THE INSULIN PUMP. AT THE BEGINNING OF THE PROCEDURE THE BLOOD GLUCOSE WAS 188 MG/DL, THEN IT INCREASED TO 300 MG/DL, AND LATER IT WAS 474 MG/DL. AT THE TIME OF THE PHONE CALL THE BLOOD GLUCOSE HAD GONE UP TO 486 MG/DL WHICH WAS TREATED WITH MANUAL INJECTION. THE CUSTOMER CALLED TO CHECK THE SETTINGS OF THE DEVICE TO MAKE SURE THAT EVERYTHING WAS SET UP CORRECTLY, WHICH IT WAS. WHILE DISCONNECTED FROM THE DEVICE, THE CUSTOMER RAN A TEST BOLUS AND INSULIN EXITED. WHILE STILL ON THE PHONE, THE CUSTOMER CHECKED THEIR BLOOD GLUCOSE AND IT HAD DECREASED TO 486 MG/DL AND LATER TO 417 MG/DL. THE CUSTOMER WAS ADVISED TO CHECK THEIR BLOOD GLUCOSE PERIODICALLY. THEY DECLINED FURTHER TROUBLESHOOTING SUE TO FATIGUE AND WANTING TO REST. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409928 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR