BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SFTWR MMT-8400 CGM MODULE IOS

    MDR report key: 19422500 · Received May 30, 2024

    Report

    Report Number
    2032227-2024-179325
    Event Type
    Malfunction
    Date Received
    May 30, 2024
    Date of Event
    May 24, 2024
    Report Date
    January 29, 2025
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    PQF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 ATTEMPT TO REPRODUCE THE REPORTED EVENT USING SIMPLERA 1.3.2 APP VERSION INSTALLED ON IPHONE 11 IOS 17.0 WITH A SENSOR WAS CONDUCTED AND CONFIRMED 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 (B)(4), VERSION F. WE COULD NOT CONDUCT A THOROUGH INVESTIGATION DUE TO THE ABSENCE OF LOGS. HOWEVER, BASED ON OUR REVIEW OF THE SAP/PO NOTES, THE MOST LIKELY CAUSE OF THIS ISSUE APPEARS TO BE INSUFFICIENT RAM OR CPU RESOURCES ON THE DEVICE. IN SUCH CASES, A LACK OF ADEQUATE RAM OR CPU CAN LEAD TO APPLICATION SLOWDOWNS OR EVEN CAUSE THE OPERATING SYSTEM TO TERMINATE THE APPLICATION, RESULTING IN A LOSS OF CONNECTION FOR THE CUSTOMER AND FAILURE TO RECEIVE ALARM NOTIFICATION S. AND AFTER STARTING THE APPLICATION, A GRAPH WILL BE DISPLAYED, WHICH WAS ALSO THE UPDATING STATUS WILL BE DISPLAYED FOR A CERTAIN TIME UNTIL PART OF THE INFORMATION IS DOWNLOADED FROM THE SENSOR TO THE APPLICATION. THEREFORE, THIS IS EXPECTED BEHAVIOR. TO ASSIST WITH THE RESOLUTION OF THE ISSUE, WE PROVIDED THE HELPLINE TEAM WITH THE FOLLOWING WORKAROUND TO ENSURE THAT IT IS ADDRESSED EFFECTIVELY: PLEASE ASK CUSTOMER PRIORITIZE USING THE SIMPLERA APP WHEN NECESSARY. ISSUE NOT CONFIRMED. 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 SOFTWARE ERROR. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-8400. CUSTOMER REPORTED WRONG TIME AND NO SENSOR GLUCOSE VALUE ON THE GRAPH. 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-8400.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1437217 SFTWR MMT-8400 CGM MODULE IOS SENSOR, GLUCOSE, INVASIVE , NON-ADJUNCTIVE PQF MEDTRONIC MINIMED MMT-8400

    Patients

    Seq Age Sex Outcome Treatment
    1 24 MO Unknown