BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUARDIAN IOS APP

    MDR report key: 20122995 · Received September 3, 2024

    Report

    Report Number
    2032227-2024-230669
    Event Type
    Malfunction
    Date Received
    September 3, 2024
    Date of Event
    August 11, 2024
    Report Date
    October 9, 2024
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN ATTEMPT TO REPRODUCE THE REPORTED EVENT USING GUARDIAN APP VERSION 1.4.0 INSTALLED ON IPHONE XR IOS 16.0 WITH TRANSMITTER WAS CONDUCTED AND CONFIRMED THAT THE ISSUE IS NOT REPRODUCED. THE SOFTWARE SUCCESSFULLY ADHERED TO THE SPECIFIED REQUIREMENTS AND PERFORMED IN ACCORDANCE WITH THE EXPECTATIONS SPECIFIED IN THE SOFTWARE REQUIREMENTS SPECIFICATIONS 10967806DOC VERSION F. WE WERE UNABLE TO CONDUCT A THOROUGH INVESTIGATION DUE TO THE LACK OF ESSENTIAL LOGS NECESSARY TO PERFORM A COMPREHENSIVE ANALYSIS. WITHOUT ACCESS TO THE REQUIRED DATA, WE ARE UNABLE TO IDENTIFY A DEFINITIVE ROOT CAUSE OF THE ISSUE. MOST LIKELY THIS WAS DUE TO BROKEN PAIRING SEQUENCE. TO ASSIST WITH THE RESOLUTION OF THE ISSUE, WE PROVIDED THE HELPLINE TEAM WITH THE FOLLOWING STEPS TO ENSURE THAT IT IS ADDRESSED EFFECTIVELY: 1. UNINSTALL GUARDIAN CONNECT APP 2. UNPAIR ALL BLUETOOTH DEVICES FROM THE DEVICE. 3. INSTALL THE GUARDIAN CONNECT APP. 4. RUN THE GUARDIAN CONNECT APP. 5. FINISH NORMAL STARTUP WITH PAIRING TRANSMITTER (GST) AND SENSOR CONNECTING. 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 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 BETWEEN TRANSMITTER AND MOBILE APPLICATION. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-8200. TROUBLESHOOTING WAS PERFORMED AND COMPLETED RESET NETWORK SETTINGS PROCESS ON MOBILE DEVICE BUT ISSUE WAS NOT RESOLVED. UNABLE TO RESOLVE WITH EXISTING TROUBLESHOOTING OR LABELED INSTRUCTIONS, ISSUE ESCALATED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. NO PRODUCT RETURN IS REQUIRED FOR MMT-8200.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1104781 GUARDIAN IOS APP SENSOR, GLUCOSE, INVASIVE MDS MEDTRONIC MINIMED MMT-8200

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Unknown