BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XMTR MMT-7821LNA GST4C REPLACEMENT

    MDR report key: 19161856 · Received April 23, 2024

    Report

    Report Number
    2032227-2024-156058
    Event Type
    Malfunction
    Date Received
    April 23, 2024
    Date of Event
    April 1, 2024
    Report Date
    April 23, 2024
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P160007
    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 NO COMMUNICATION OTHER DEVICE TO MOBILE. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-7821LNA, CSS7200. TRANSMITTER IS NOT ACTIVE/CONNECTED WITH APP. TRANSMITTER LED LIGHT DIDNOT BLINK WHEN CONNECTED TO SENSOR. ADVISED TO FORCE CLOSE APP ANDRELAUNCH. TRANSMITTER DID NOT BLINK WHEN CONNECTED TO TESTER. ADVISED TOATTACH TRANSMITTER TO CHARGER TO DETERMINE IF LED LIGHT BLINKS WHENREMOVED FROM CHARGER.THE CUSTOMER CALLED FOR AN ISSUE NOT COVERED BY EXISTING TROUBLESHOOTINGGUIDES. REFER TO THE EVENT DESCRIPTION FOR MORE DETAILS. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. NO PRODUCT RETURN IS REQUIRED FOR MMT-7821LNA. NO PRODUCT RETURN IS REQUIRED FOR CSS7200.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    934453 XMTR MMT-7821LNA GST4C REPLACEMENT SENSOR, GLUCOSE, INVASIVE MDS MEDTRONIC MINIMED MMT-7821LNA 1107667

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male