BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUARDIAN ANDROID¿ APP

    MDR report key: 19218801 · Received May 1, 2024

    Report

    Report Number
    2032227-2024-161579
    Event Type
    Malfunction
    Date Received
    May 1, 2024
    Date of Event
    April 16, 2024
    Report Date
    September 18, 2024
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    "AN ATTEMPT TO REPRODUCE THE REPORTED EVENT USING GUARDIAN CONNECT - SOFTWARE VERSION 3.5.0 INSTALLED ON SAMSUNG S9+ ANDROID 10 WITH A TRANSMITTER WAS CONDUCTED AND CONFIRMED THE ISSUE WAS REPRODUCED. THE SOFTWARE DID NOT SUCCESSFULLY ADHERE TO THE SPECIFIED REQUIREMENTS AND DID NOT PERFORMED IN ACCORDANCE WITH THE EXPECTATIONS SPECIFIED IN THE SOFTWARE REQUIREMENTS SPECIFICATIONS ES10582DOC VERSION S. AFTER CONDUCTING A THOROUGH INVESTIGATION, WE HAVE FOUND THAT IF THE INSULIN DOSE ENTERED INITIALLY IS 0.8 THE REPORT SHOWS ONLY THE 0, IF THE INSULIN DOSE ENTERED IS 1.2, THE REPORT SHOWS ONLY 1.Â.  THE ESF NUMBER THAT CORRESPONDS TO THE REPORTED ENHANCEMENT IS: (B)(4).. THERE ARE NOT ANY RESOLUTION STEPS, ISSUE COULD BE FIXED IN THE NEXT RELEASE. TESTING PERFORMED BY: (B)(4). INVESTIGATION PERFORMED BY:(B)(4). AFC CODE: FA21AF SOFTWARE ANOMALY (DEFECT). INVESTIGATION COMPLETION DATE: 07/JUN/24 4:42 AM. " 5080074 GUARDIAN CONNECT (STANDALONE CGM, GC). 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 REPORT ANOMALY. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-8201. TROUBLESHOOTING WAS PERFORMED, UNABLE TO RESOLVE THE ISSUE AND THE ISSUE WAS ESCALATED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. NO PRODUCT RETURN IS REQUIRED FOR MMT-8201.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154854 GUARDIAN ANDROID¿ APP SENSOR, GLUCOSE, INVASIVE MDS MEDTRONIC MINIMED MMT-8201

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Unknown