BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSMITTER MMT-7841ZN GST5G US

    MDR report key: 19002100 · Received March 29, 2024

    Report

    Report Number
    2032227-2024-148362
    Event Type
    Malfunction
    Date Received
    March 29, 2024
    Date of Event
    March 15, 2024
    Report Date
    April 1, 2024
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    PQF
    PMA / PMN Number
    P160017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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. 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.

    Additional Manufacturer Narrative · 0

    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. 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 REPORTED A LOSS OF COMMUNICATION BETWEEN THE TRANSMITTER AND THE PUMP. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-7841ZN, MMT-1884, MMT-7040A. TROUBLESHOOTING WAS PERFORMED BUT THE ISSUE WAS NOT RESOLVED. THE ALARM(S) THE CUSTOMER RECEIVED WAS A LOST SENSOR SIGNAL. THE EVENT OCCURRED BEFORE THE LOSS OF COMMUNICATION BEGAN BY SITTING AROUND. THE CORRECT TRANSMITTER ID WAS PROGRAMMED INTO THE PUMP. THE CUSTOMER DECLINED TO TROUBLESHOOT FURTHER. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. NO PRODUCT RETURN IS REQUIRED FOR MMT-7841ZN. NO PRODUCT RETURN IS REQUIRED FOR MMT-1884. NO PRODUCT RETURN IS REQUIRED FOR MMT-7040A.

    Description of Event or Problem · 0

    THE INITIAL CASE WAS SUBMITTED IN ERROR AND HENCE UPDATING THE PMA/510(K) NUMBER IN SECTION G3 / G4 TO P160017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2592746 TRANSMITTER MMT-7841ZN GST5G US SENSOR, GLUCOSE, INVASIVE , NON-ADJUNCTIVE PQF MEDTRONIC MINIMED MMT-7841ZN 1118469

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female