BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAL

    MDR report key: 7489774 · Received May 7, 2018

    Report

    Report Number
    3004209178-2018-69419
    Event Type
    Injury
    Date Received
    May 7, 2018
    Date of Event
    March 22, 2018
    Report Date
    May 7, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    00643169513891
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    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

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD HIGH BLOOD GLUCOSE. THE CUSTOMER'S CURRENT BLOOD GLUCOSE IS 409 MG/DL AND LAST WEEK BLOOD GLUCOSE WAS 210, 318, 361, 277 MG/DL. THE CUSTOMER DECLINED TROUBLESHOOTING ON INSULIN PUMP. THE CUSTOMER TREATED HIGH BLOOD GLUCOSE WITH BOLUS WITH THE INSULIN PUMP. THE CUSTOMER WAS NEITHER HOSPITALIZED NOR ADMITTED FOR HIGH BLOOD GLUCOSE. BASED ON CUSTOMER REPORT CUSTOMER DOES NOT ALLEGE PUMP WAS UNDER DELIVERING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333906 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAL PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAL A5723LNALJ 00643169513891

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other