BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 8719781 · Received June 20, 2019

    Report

    Report Number
    2032227-2019-19314
    Event Type
    Injury
    Date Received
    June 20, 2019
    Date of Event
    October 2, 2017
    Report Date
    June 20, 2019
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED THE HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE WAS 250, 65, 200, 514, 557, 278, 108 MG/DL. THE CUSTOMER CONTACTED THEIR DOCTOR AND THE DOCTOR RECOMMENDED HER GO TO EMERGENCY ROOM. THE CUSTOMER EXPERIENCED THE SYMPTOMS OF HYPERGLYCEMIA, DIFFICULTY BREATHING. THE CUSTOMER WAS TREATED WITH THE MANUAL INJECTION AND INSULIN PUMP. THE TROUBLESHOOTING WAS NOT MENTIONED FOR THE HIGH BLOOD GLUCOSE. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513344 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 Other