BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3942828 · Received July 17, 2014

    Report

    Report Number
    2032227-2014-04439
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 14, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    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 OF 420 MG/DL. HER BASAL RATES WERE MODIFIED ON JUNE 13, 2014 AND SINCE THEN, THE CUSTOMER WAS FEELING UNWELL. THE CUSTOMER CONTACTED HER HEALTHCARE PROVIDER AND TREATED FOR HER HIGH BLOOD GLUCOSE. TROUBLESHOOTING WITH THE INSULIN PUMP WAS PERFORMED AND IT WAS FOUND THAT THE CANNULA ON THE INFUSION SET WAS BENT TO ONE SIDE. ADDITIONALLY, AIR BUBBLES WERE FOUND IN THE INSULIN VIAL. THE CUSTOMER WAS ADVISED TO CHANGE THE INFUSION SET, RESERVOIR AND INSULIN. THE HIGH PRESSURE TEST WAS PERFORMED AND PASSED. THE BASAL RATES WERE REPORTEDLY GOING TO BE INCREASED BY THE CUSTOMER'S DOCTOR. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419206 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523RNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR