BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSMITTER MMT-7841ZN GST5G US

    MDR report key: 20406505 · Received October 9, 2024

    Report

    Report Number
    2032227-2024-251035
    Event Type
    Malfunction
    Date Received
    October 9, 2024
    Date of Event
    September 18, 2024
    Report Date
    October 9, 2024
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    PQF
    PMA / PMN Number
    P160017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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. 2032227-2024-251035 MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED LOST SENSOR ALARM, SENSOR UPDATING/SENSOR GLUCOSE NOT AVAILABLE, LOSS OF COMMUNICATION BETWEEN THE TRANSMITTER AND THE PUMP. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-7040A, MMT-7841ZN, MMT-1884. TROUBLESHOOTING COULD NOT BE PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. IT WAS UNKNOWN WHETHER CUSTOMER WILL CONTINUE/DISCONTINUE THE USE OF PRODUCT. NO PRODUCT RETURN IS REQUIRED FOR MMT-7040A. NO PRODUCT RETURN IS REQUIRED FOR MMT-7841ZN. NO PRODUCT RETURN IS REQUIRED FOR MMT-1884.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686913 TRANSMITTER MMT-7841ZN GST5G US SENSOR, GLUCOSE, INVASIVE , NON-ADJUNCTIVE PQF MEDTRONIC MINIMED MMT-7841ZN 1113798

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male