BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUARDIAN IOS APP

    MDR report key: 18289708 · Received December 8, 2023

    Report

    Report Number
    2032227-2023-313857
    Event Type
    Malfunction
    Date Received
    December 8, 2023
    Date of Event
    November 16, 2023
    Report Date
    January 22, 2024
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT SUMMARY: CARE PARTNER REPORTS NOT RECEIVING SAME ALERTS AS PATIENT. INVESTIGATION/TESTING SUMMARY: AN ATTEMPT TO REPRODUCE THE ISSUE WAS NOT CONDUCTED, DUE TO THEIR BEING EVIDENCE IN THE SMS LOGS THAT MESSAGES WERE GOING OUT TO CARE PARTNERS. CARELINK SUPPORT TEAM INVESTIGATED THE DATABASE NOTIFICATION AND SMS LOGS, AS WELL AS THE SMS VENDOR LOGS AND CONFIRMED THAT ALL SMS NOTIFICATIONS WERE GOING OUT TO ALL CARE PARTNERS. SHARED FOLLOWING TROUBLESHOOTING STEPS WITH HELPLINE: - PATIENT SHOULD NOT IMMEDIATELY CLEAR NOTIFICATION ALERTS. - TRANSLATION REQUEST WILL NEED TO BE A SEPARATE TICKET. - SENSOR ISSUE SHOULD BE REPORTED TO SENSOR TEAM (RELAYED INFORMATION TO SENSOR TEAM THROUGH EMAIL, THEY DO NOT HAVE A JIRA BOARD). 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: PATIENT IMMEDIATELY CLEARING NOTIFICATIONS AND CARE PARTNERS MISUNDERSTANDING SMS NOTIFICATION CONTENT ANALYSIS SUMMARY: NO ISSUE FOUND WITHIN CARELINK SMS NOTIFICATIONS. HELPLINE CONFIRMED THAT CARE PARTNERS HAD RECEIVED MATCHING ALERTS TO PATIENT. INFORMED HELPLINE HOW TO ADDRESS THEIR OTHER CONCERNS. 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. 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 THERE'S NO COMMUNICATION OF MOBILE DEVICE WITH THE TRANSMITTER. IT WAS REPORTED THAT THE GUARDIAN CONNECT APP WAS UNABLE TO COMMUNICATE WITH THE TRANSMITTER. IT WAS FOUND THAT THE CARE PARTNER WAS NOT RECEIVING SENSOR ALERTS LIKE SENSOR CONNECTED AND CHANGE SENSOR ALARMS. PARTIAL TROUBLESHOOTING WAS DONE AND THE ISSUE WAS ESCALATED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. IT WAS UNKNOWN WHETHER THE CUSTOMER WILL CONTINUE THE USE OF THE APP AND THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1128967 GUARDIAN IOS APP SENSOR, GLUCOSE, INVASIVE MDS MEDTRONIC MINIMED MMT-8200

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown