BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSMITTER MMT-7841ZW GST5G OUS

    MDR report key: 18309075 · Received December 12, 2023

    Report

    Report Number
    2032227-2023-315232
    Event Type
    Malfunction
    Date Received
    December 12, 2023
    Date of Event
    November 20, 2023
    Report Date
    December 12, 2023
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    PQF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    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. SELECT PATIENT INFORMATION CANNOT BE PROVIDED DUE TO REGIONAL PRIVACY REGULATIONS. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Description of Event or Problem · 0

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER HAD A LOSS OF COMMUNICATION ISSUE BETWEEN THE INSULIN PUMP AND TRANSMITTER. TROUBLESHOOTING WAS PERFORMED AND IT WAS UNKNOWN WHETHER THE ISSUE WAS RESOLVED OR NOT. THE ALARM(S) CUSTOMER REPORTS RECEIVED A LOST SIGNAL. THE EVENT(S)/ACTIVITY(IES) OCCURRED BEFORE THE LOSS OF COMMUNICATION BEGAN WITH THE NORMAL USE. THE TRANSMITTER ID WAS PROGRAMMED INTO THE PUMP. THE CUSTOMER STATED THE TRANSMITTER LED DID NOT BLINK ON AND OFF. THE CUSTOMER STATES THE TRANSMITTER LED BLINKED ON AND OFF WHEN IT WAS DISCONNECTED FROM THE CHARGER. THE CUSTOMER STATES THE TRANSMITTER LED DID NOT BLINK WHEN IT WAS CONNECTED TO THE TESTER. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. IT WAS UNKNOWN WHETHER THE CUSTOMER WILL CONTINUE THE USE OF THE DEVICE. THE TRANSMITTER WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1111094 TRANSMITTER MMT-7841ZW GST5G OUS SENSOR, GLUCOSE, INVASIVE, NON-ADJUNCTIVE PQF MEDTRONIC MINIMED MMT-7841ZW 1073256

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown