BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 8825200 · Received July 25, 2019

    Report

    Report Number
    2032227-2019-35716
    Event Type
    Injury
    Date Received
    July 25, 2019
    Date of Event
    July 6, 2019
    Report Date
    July 24, 2019
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    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 VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE AND INSULIN PUMP ALLEGING UNDER DELIVERY. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 506 MG/DL AT THE TIME OF INCIDENT AND THE OTHER BLOOD GLUCOSE OF THE CUSTOMER WERE 512 MG/DL AND 524 MG/DL. CUSTOMER WAS USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER REPORTED THAT AUTO MODE FEATURE WAS ACTIVE AND AUTOMATICALLY ADJUSTING INSULIN DELIVERY AT TIME OF HIGH BLOOD GLUCOSE EVENT. CUSTOMER TREATED WITH INSULIN PUMP. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND DECLINED FOR HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619445 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other UNOMED SET, OZP-MMT-7020A ¿SNSR