BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK PERSONAL MMT-7333

    MDR report key: 16173868 · Received January 16, 2023

    Report

    Report Number
    2032227-2023-118484
    Event Type
    Malfunction
    Date Received
    January 16, 2023
    Date of Event
    September 11, 2022
    Report Date
    November 7, 2023
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    CGA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE CARELINK WEB PAGE FOR THE CARE PARTNER ACCOUNT APPEARS STATUS ""INFO UNAVAILABLE"". WE ASKED THE HELPLINE TO CHECK THE CARELINK WEB PAGE FOR PATIENTS. AN ANALYSIS WAS PERFORMED. IT IS THOUGHT THAT THE CAUSE OF THIS PROBLEM WAS DUE TO A PROBLEM WAS IN THE COMMUNICATION BETWEEN CARELINK FOR PATIENTS AND CARELINK FOR CARE LINK PARTNERS. THERE WERE 3 ATTEMPTS TO REPRODUCE THE REPORTED PROBLEM NAMELY: 1. PERFORM NORMAL STARTUP. 2. WAIT FOR CALIBRATION REQUIRED ALERT. 3. CALIBRATE THE SENSOR. 4. WAIT FOR SG VALUE. 5. NAVIGATE TO CARELINK WEB PAGE FOR CARE PARTNER. 6. CHECK THE DATA ON THE GRAPH. BUT WE WERE UNABLE TO REPRODUCE THE PROBLEM INDICATING THAT THE SOFTWARE IS NOT WORKING PROPERLY ON SAMSUNG GALAXY S9+ / ANDROID 10 AND ON APP VERSION 3.4.3.(TRANSMITTER SN (B)(6)). THE SOFTWARE IS FUNCTIONING PROPERLY AND NO FAILURE HAS BEEN IDENTIFIED. HELPLINE CONFIRMED THE COMPLAINT HAS BEEN RESOLVED BUT DID NOT ELABORATE ON HOW IT WAS RESOLVED. THEREFORE THE TICKET WAS CLOSED WITH NO RESOLUTION. THE DATA FROM THE GUARDIAN CONNECT APP IS SENT TO THE CARELINK WEBSITE, SO THE LIKELY CAUSE WOULD BE DUE TO A COMMUNICATION ISSUE BETWEEN CARELINK AND CARELINK PARTNER. 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. INFORMATION FOR THE ANALYSIS SUMMARY HAS BEEN ADDED WHICH WAS MISSED IN THE INITIAL REPORT. THE INFORMATION HAS BEEN PROVIDED AS PER THE DEVICE EVALUATION PROCESS IN SECTIONS H2, H3, H6 AND H10 OF THIS REPORT.

    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, 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

    MEDTRONIC RECEIVED INFORMATION THAT SOFTWARE ERROR OCCURRED. THERE WAS NO ADVERSE IMPACT OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1135170 CARELINK PERSONAL MMT-7333 GLUCOSE OXIDASE, GLUCOSE CGA MEDTRONIC MINIMED MMT-7333

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown