BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSMITTER MMT-7841ZN GST5G US

    MDR report key: 19789971 · Received July 22, 2024

    Report

    Report Number
    2032227-2024-206886
    Event Type
    Injury
    Date Received
    July 22, 2024
    Date of Event
    June 14, 2024
    Report Date
    July 21, 2024
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    PQF
    PMA / PMN Number
    P160017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED LOST SENSOR ALARM, HARM REPORTED WITH NO REPORTED ALLEGATION OF A DEVICE MALFUNCTION, DHR REQUESTED - OTHER REASONS. THE CUSTOMER REPORTED BLOOD GLUCOSE VALUE OF 38 MG/DL. THE CUSTOMER REPORTED HYPOGLYCEMIA TREATED WITH GLUCOSE/CARB INTAKE. CUSTOMER REPORTED THE FOLLOWING LED UP TO THE EVENT: NO TROUBLESHOOTING WAS IDENTIFIED. THE EVENT INVOLVED PRODUCT(S) MMT-7040A, MMT-342, MMT-431A, MMT-1884. CUSTOMER REPORTED LOW BGS. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. NO PRODUCT RETURN IS REQUIRED FOR MMT-7040A. NO PRODUCT RETURN IS REQUIRED FOR MMT-342. NO PRODUCT RETURN IS REQUIRED FOR MMT-431A. NO PRODUCT RETURN IS REQUIRED FOR MMT-1884. FRN-MMT-332A-RSVR, UNOMED, OZP-MMT-7040A-SNSR. UPDATED SUMMERY: IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED LOST SENSOR ALARM, HARM REPORTED WITH NO REPORTED ALLEGATION OF A DEVICE MALFUNCTION, DHR REQUESTED - OTHER REASONS. THE CUSTOMER REPORTED BLOOD GLUCOSE VALUE OF 38 MG/DL. THE CUSTOMER REPORTED HYPOGLYCEMIA TREATED WITH GLUCOSE/CARB INTAKE. CUSTOMER REPORTED THE FOLLOWING LED UP TO THE EVENT: NO TROUBLESHOOTING WAS IDENTIFIED. THE EVENT INVOLVED PRODUCT(S) MMT-7040A, MMT-342, MMT-431A, MMT-7841ZN, MMT-1884. CUSTOMER REPORTED LOW BGS. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. NO PRODUCT RETURN IS REQUIRED FOR MMT-7040A. NO PRODUCT RETURN IS REQUIRED FOR MMT-342. NO PRODUCT RETURN IS REQUIRED FOR MMT-431A. NO PRODUCT RETURN IS REQUIRED FOR MMT-1884. NO PRODUCT RETURN IS REQUIRED FOR MMT-7841ZN. FRN-MMT-332A-RSVR, UNOMED, OZP-MMT-7040A-SNSR, OZP-MMT-7841ZN-TRANS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1119150 TRANSMITTER MMT-7841ZN GST5G US SENSOR, GLUCOSE, INVASIVE , NON-ADJUNCTIVE PQF MEDTRONIC MINIMED MMT-7841ZN 1133237

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Female Other FRN-MMT-332A-RSVR, UNOMED, OZP-MMT-7040A-SNSR