BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 6765838 · Received August 3, 2017

    Report

    Report Number
    2032227-2017-34101
    Event Type
    Injury
    Date Received
    August 3, 2017
    Date of Event
    July 13, 2017
    Report Date
    July 19, 2018
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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.

    Additional Manufacturer Narrative · 1

    THE INFORMATION PROVIDED WERE INCORRECT WITH THE INITIAL REPORT. THE CORRECT INFORMATION HAS BEEN PROVIDED WITH THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CLINICAL RESEARCH ENTITY THAT THE CUSTOMER RECEIVED EMERGENCY MEDICAL ASSISTANCE DUE TO LOW BLOOD GLUCOSE ON (B)(6) 2017 WITH BLOOD GLUCOSE OF AROUND 26 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS DRIVING AT THE TIME OF THE INCIDENT. THE CUSTOMER DROVE ONTO THE EMBANKMENT OF THE ROAD WHILE DRIVING TO GET FOOD. THE CUSTOMER WAS GIVEN ORAL CARBS TO TREAT. THE CUSTOMER EXPERIENCED SYMPTOMS SUCH AS FEELING LOW AND DISORIENTATION. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENT. TROUBLESHOOTING WAS NOT COMPLETED. CUSTOMER STATES PUMP USE WAS DISCONTINUED AT THE EMERGENCY ROOM. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543280 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