BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SFTWR, CSS7201 GUARDIAN ANDROID APP

    MDR report key: 17593648 · Received August 22, 2023

    Report

    Report Number
    2032227-2023-258560
    Event Type
    Malfunction
    Date Received
    August 22, 2023
    Date of Event
    August 2, 2023
    Report Date
    December 6, 2023
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P160007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    "COMPLAINT SUMMARY: USER REPORTED BEING UNABLE TO LOGIN TO CARELINK AFTER REPORTED SERVICE OUTAGE. INVESTIGATION/TESTING SUMMARY: AFTER CONDUCTING A THOROUGH INVESTIGATION OF DATABASE SSO LOGS AND CSR FOR USERS LOGIN METRICS, WE CAN CONFIRM THAT USER WAS ACTIVELY LOGGED IN AND UPLOADING PERIODIC DATA TO CARELINK SUCCESSFULLY. IT WAS ALSO CONFIRMED THROUGH DATABASE LOGS THAT THERE WERE NO FAILED LOGIN ATTEMPTS IN USER'S CARELINK LOGIN HISTORY. ISSUE DID NOT LAY WITHIN THEIR CARELINK ACCOUNT. MOBILE TEAM HAD ALSO INVESTIGATED ON PREVIOUS VERSION OF THIS TICKET AND CONFIRMED THROUGH THEIR AVAILABLE DIAGNOSTIC LOGS THAT THE APPLICATION WAS NOT REPORTING ANY LOGIN ISSUES. INFORMED HELPLINE TO ADVISE USER TO REATTEMPT LOGIN. HELPLINE CONFIRMED THAT USER WAS FINALLY ABLE TO LOGIN FROM THEIR ANDROID PHONE AND THAT THEY WOULD BE REACHING OUT TO THE PHONES MANUFACTURER. THIS ISSUE HAD BEEN RESOLVED HOWEVER, THEY OPENED A NEW TICKET STATING THE ISSUE WAS AGAIN REOCCURRING. TICKET FOR REFERENCE IS(B)(4). WHICH IS UNDER INVESTIGATION. THE SOFTWARE SUCCESSFULLY ADHERED TO THE SPECIFIED REQUIREMENTS AND PERFORMED IN ACCORDANCE WITH THE EXPECTATIONS SPECIFIED IN THE (B)(4). VERSION (B)(4). (MOST LIKELY) ROOT CAUSE: MOST LIKELY CAUSED BY SOME SETTING OR CONFIGURATION LOCAL TO USER'S MOBILE PHONE. ANALYSIS SUMMARY: ISSUE LAYS OUTSIDE OF CARELINK AND MOBILE APPLICATION. USER'S ACCOUNT CAN BE LOGGED INTO AND MOBILE APPLICATION WORKS ON OTHER MOBILE DEVICES. ISSUE MUST LAY WITH USER'S ANDROID DEVICE. HELPLINE REPORTED USER WAS FINALLY ABLE TO LOGIN FROM THEIR ANDROID DEVICE. 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.

    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 SUDDENLY GOT LOGGED OUT OF THE GUARDIAN APPLICATION. TRIED TO RE-INSTALL THE APPLICATION BUT THE ISSUE WAS NOT SOLVED. TROUBLESHOOTING WAS PERFORMED AND THE ISSUE COULD NOT BE RESOLVED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. IT WAS UNKNOWN WHETHER THE CUSTOMER WILL CONTINUE USING THE DEVICE. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2331042 SFTWR, CSS7201 GUARDIAN ANDROID APP SENSOR, GLUCOSE, INVASIVE MDS MEDTRONIC MINIMED CSS7201

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown