BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 7591919 · Received June 12, 2018

    Report

    Report Number
    2032227-2018-05178
    Event Type
    Injury
    Date Received
    June 12, 2018
    Date of Event
    September 19, 2014
    Report Date
    June 12, 2018
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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

    CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED DIFFERENT BLOOD GLUCOSE LEVEL WAS 45, 59, 311, 22, 212, 216, 273, 222MG/DL. CUSTOMER EXPERIENCED LOW BLOOD GLUCOSE LEVEL WAS 45MG/DL . CUSTOMER HAD SYMPTOMS LIKE EXCESSIVE THIRST KETONES IN URINE .CUSTOMER WAS LOW BLOOD GLUCOSE LEVEL TREATED WITH INSULIN PUMP. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL AND CANNULA WAS NOT BENT OR NOT OCCLUDED .TROUBLESHOOTING WAS PERFORMED. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432824 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 53 YR Other