BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SFTWR, CSS7201 GUARDIAN ANDROID APP

    MDR report key: 18298984 · Received December 11, 2023

    Report

    Report Number
    2032227-2023-314319
    Event Type
    Malfunction
    Date Received
    December 11, 2023
    Date of Event
    November 17, 2023
    Report Date
    August 13, 2024
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P160007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN ATTEMPT TO REPRODUCE THE REPORTED EVENT USING XIAOMI 12 WITH ANDROID 12 APP VERSION 3.4.3 WAS CONDUCTED AND CONFIRMED THE ISSUE IS REPRODUCED. THE SOFTWARE SUCCESSFULLY ADHERED TO THE SPECIFIED REQUIREMENTS AND PERFORMED IN ACCORDANCE WITH THE EXPECTATIONS SPECIFIED IN THE SOFTWARE REQUIREMENTS SPECIFICATIONS (B)(4) VERSION R. ACCORDING TO GOOGLE'S GUIDELINES, IF APPS WANT TO STAY ACCESSIBLE TO USERS WITH NEWER ANDROID SYSTEMS, THEY NEED TO BE DESIGNED FOR API LEVEL 31 OR HIGHER. OTHERWISE, THEY'LL ONLY WORK ON DEVICES WITH OLDER ANDROID SYSTEMS. CURRENTLY, GUARDIAN CONNECT VERSION 3.4.3 IS DESIGNED FOR API LEVEL 29, WHICH MEANS IT MIGHT NOT WORK PROPERLY ON NEWER ANDROID DEVICES. TO FIX THIS, WE'VE CREATED A TASK (ACR NUMBER 4672394) TO UPDATE THE GUARDIAN CONNECT APP. THE GOAL IS TO UPGRADE IT TO SUPPORT ANDROID SDK LEVEL 33. HERE'S WHAT NEEDS TO BE DONE FOR THE GC US 4.3.0 (ANDROID) VERSION, WE'LL UPGRADE IT FROM USING SDK LEVEL 30 TO LEVEL 33. FOR THE GC OUS 3.5.0 (ANDROID) VERSION, WE'LL DO THE SAME, UPGRADING IT FROM SDK LEVEL 29 TO LEVEL 33. THIS ISSUE WILL BE RESOLVED IN THE UPCOMING GUARDIAN CONNECT RELEASE/S. TO ASSIST WITH THE RESOLUTION , WE PROVIDED THE HELPLINE TEAM WITH THE FOLLOWING WORKAROUND TO ENSURE THAT IT IS ADDRESSED EFFECTIVELY: ""YOU CAN TRY TO USE AT FIRST THE DEVICE WITH ANDROID 10 FOR GUARDIAN CONNECT APP INSTALLATION AND THAN WITH SAME(GOOGLE) ACCOUNT TRY TO INSTALL GUARDIAN CONNECT APP ON THE YOUR CURRENT DEVICE. 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.

    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 COULD NOT INSTALL THE GUARDIAN CONNECT APP FROM PLAYSTORE. TROUBLESHOOTING WAS PERFORMED BUT CUSTOMER WAS UNABLE TO INSTALL GUARDIAN CONNECT APP. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. IT WAS UNKNOWN IF THE CUSTOMER WILL CONTINUE THE USE OF THE DEVICE OR NOT. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2044372 SFTWR, CSS7201 GUARDIAN ANDROID APP SENSOR, GLUCOSE, INVASIVE MDS MEDTRONIC MINIMED CSS7201

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Unknown