BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3942376 · Received July 17, 2014

    Report

    Report Number
    3004209178-2014-87583
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 15, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 EXPERIENCED HIGH BLOOD GLUCOSE LEVELS SINCE THE LAST WEEK WHEN SHE CHANGED HER SET. THE BLOOD GLUCOSE READING WAS 225 MG/DL. THE CUSTOMER STATED THAT SHE CHANGED HER SET IN THE MORNING AND HER BLOOD GLUCOSE READING WENT FROM 350 MG/DL TO 225 MG/DL, BUT THERE WAS NO CORRECTION WITH A BOLUS; SHE EXPLAINED THAT HER BLOOD GLUCOSE LEVELS WERE SLIGHTLY COMING DOWN BECAUSE SHE WAS RUNNING OFF OF THE BASAL RATES. ASSISTED CUSTOMER WITH BOLUS WIZARD. THE CUSTOMER STATED SHE WAS GOING TO BOLUS AND CHECK HER BLOOD GLUCOSE, THEN CALL BACK IF HER BLOOD GLUCOSE LEVELS WERE STILL HIGH. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419752 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 66 YR