BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SFTWR, CSS7201 GUARDIAN ANDROID APP

    MDR report key: 19612480 · Received June 26, 2024

    Report

    Report Number
    2032227-2024-192164
    Event Type
    Malfunction
    Date Received
    June 26, 2024
    Date of Event
    June 7, 2023
    Report Date
    August 20, 2024
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P160007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    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 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

    AN INVESTIGATION INTO THIS BEHAVIOUR WAS CONDUCTED ON GCN-44 (HTTPS://MEDTRONICDIABETES.ATLASSIAN.NET/BROWSE/GCN-44). THIS BEHAVIOUR IS ACKNOWLEDGED AS A KNOWN CHARACTERISTIC OF THE ANDROID PLATFORM. THE ANDROID DEVELOPER PORTAL PROVIDED INFORMATION TO USERS REGARDING THIS MATTER, WHICH CAN BE FOUND HERE: HTTPS://DEVELOPER.ANDROID.COM/TRAINING/MONITORING-DEVICE-STATE/DOZE-STANDBY. ADDITIONALLY, FURTHER INFORMATION ABOUT THIS BEHAVIOUR FROM THE ANDROID PERSPECTIVE CAN BE FOUND AT THE FOLLOWING SOURCES: HTTPS://WWW.TECHREPUBLIC.COM/ARTICLE/HOW-TO-REMOVE-ANDROID-APPS-FROM-THE-BATTERY-OPTIMIZATION-LIST/ HTTPS://COMMUNITY.ONEPLUS.COM/THREAD/849162. THE SOFTWARE SUCCESSFULLY ADHERED TO THE SPECIFIED REQUIREMENTS AND PERFORMED IN ACCORDANCE WITH THE EXPECTATIONS SPECIFIED IN THE SOFTWARE REQUIREMENTS SPECIFICATIONS ES10582DOC_R. UPON CONDUCTING A COMPREHENSIVE INVESTIGATION, IT WAS DETERMINED THAT THE CUSTOMER MISUNDERSTOOD THE IMPACT OF THE ""BATTERY OPTIMIZATION"" FEATURE OF THE ANDROID OPERATING SYSTEM ON THE GUARDIAN CONNECT APP. TO EFFECTIVELY ADDRESS THIS ISSUE, WE HAVE PROVIDED THE HELPLINE TEAM WITH THE FOLLOWING STEPS: THE DEFAULT SETTING FOR APP BATTERY OPTIMIZATION ON ANDROID OS IS ""OPTIMIZE."" PLEASE INSTRUCT THE HELPLINE TO GUIDE THE CUSTOMER IN CHANGING THIS SETTING TO ""DON'T OPTIMIZE"" SPECIFICALLY FOR THE GUARDIAN CONNECT APP. IT IS CRUCIAL TO INFORM THE HELPLINE ABOUT THE NECESSITY OF KEEPING THE ""BATTERY OPTIMIZATION"" SETTING FOR THE GUARDIAN CONNECT APP IN THE ""DON'T OPTIMIZE"" STATE TO ENSURE ITS PROPER FUNCTIONALITY. 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) CSS7201. TROUBLESHOOTING WAS PERFORMED AND UNABLE TO RESOLVE WITH EXISTING TROUBLESHOOTING OR LABELED INSTRUCTIONS, ISSUE ESCALATED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. NO PRODUCT RETURN IS REQUIRED FOR CSS7201.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702989 SFTWR, CSS7201 GUARDIAN ANDROID APP SENSOR, GLUCOSE, INVASIVE MDS MEDTRONIC MINIMED CSS7201

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Unknown