BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SENSOR

    MDR report key: 22940754 · Received September 2, 2025

    Report

    Report Number
    2032227-2025-243530
    Event Type
    Injury
    Date Received
    September 2, 2025
    Date of Event
    October 4, 2023
    Report Date
    August 24, 2025
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW PER CAPA 686868. 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. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED SENSOR GLUCOSE VS. BLOOD GLUCOSE. BLOOD GLUCOSE VALUE WAS 440 MG/DL WHILE SENSOR GLUCOSE VALUE WAS 181 MG/DL. THE CUSTOMER REPORTED HYPERGLYCEMIA. SYMPTOMS INCLUDED NAUSEA AND FEELING WEAK. TREATED WITH INSULIN PUMP AND MANUAL INJECTION. AUTO MODE WAS IN USE. WAS ADVISED TO CONSIDER CHANGING THE INSULIN, RESERVOIR, AND INFUSION SET. THE EVENT INVOLVED PRODUCT(S) UNK_SENSOR. THE SENSOR WAS WORN FOR UNKNOWN NUMBER OF DAYS. DECLINED TROUBLESHOOTING FOR SG V BG. NO PRODUCT RETURN IS EXPECTED FOR UNK_SENSOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240823 UNKNOWN SENSOR SENSOR, GLUCOSE, INVASIVE MDS MEDTRONIC MINIMED UNK_SENSOR

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Unknown FRN-MMT-332A-RSVR, UNOMED INF SET