BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SFTWR MMT-8061 INPEN APP ANDROID

    MDR report key: 19307276 · Received May 14, 2024

    Report

    Report Number
    3012822846-2024-00512
    Event Type
    Malfunction
    Date Received
    May 14, 2024
    Date of Event
    April 30, 2024
    Report Date
    March 11, 2025
    Manufacturer
    COMPANION MEDICAL INC
    Product Code
    NDC
    PMA / PMN Number
    K201337
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN ATTEMPT TO REPRODUCE THE REPORTED EVENT USING THE INPEN APP (SOFTWARE VERSION 7.1.1.0) INSTALLED ON SAMSUNG GALAXY S20 PLUS, (ANDROID 13) WAS CONDUCTED AND CONFIRMED THE ISSUE IS REPRODUCIBLE. THIS ISSUE IS CONFIRMED. AFTER CONDUCTING A THOROUGH INVESTIGATION, WE DISCOVERED THAT WHEN THERE IS A CHANGE IN DEVICE TYPE, FIRMWARE VERSION, SOFTWARE VERSION, OR MODEL NUMBER, THE BLE AND SIMPLERA PERIODIC DATA ARE SUPPOSED TO BE HANDED OVER TO COSMOS. CUMULUS TRACKS THIS INFORMATION IN ELASTICACHE, WHICH CLEARS AFTER 30 MINUTES (WITH AN INACTIVITY PERIOD OF 120 MINUTES FOR BLE, AND ALL SIMPLERA PERIODIC DATA MARKED FOR HANDOVER). HOWEVER, THE CUMPERIODICPACKETINACTIVITYDETECTOR IS CURRENTLY FAILING. AS A RESULT, WHEN A USER SWITCHES DEVICES (SUCH AS FROM GC TO SIMPLERA), THE DATA ISN¿T PROPERLY HANDED OVER TO COSMOS, LEADING TO MISSING DEVICE INFORMATION AND THE DEVICE CHANGE NOT APPEARING ON REMOTE MONITOR. THE ROOT CAUSE OF THE ISSUE IS A MISMATCH BETWEEN THE JAVA VERSION IN THE DEPLOYED CODE AND THE LAMBDA CONFIGURATION. TO RESOLVE THIS, WE UPGRADED THE JDK VERSION OF THE CUMPERIODICPACKETINACTIVITYDETECTOR LAMBDA ON OUS PROD TO JDK 17. THE SOFTWARE SUCCESSFULLY ADHERED TO THE SPECIFIED REQUIREMENTS AND PERFORMED IN ACCORDANCE WITH THE EXPECTATIONS SPECIFIED IN THE SOFTWARE REQUIREMENT AND SPECIFICATION DOCUMENT LISTED BELOW UNDER (B)(4). STEPS TO RESOLVE THE ISSUE: 1. ACCESSED THE AWS LAMBDA MANAGEMENT CONSOLE. 2. SELECTED THE LAMBDA FUNCTION RESPONSIBLE FOR INACTIVITY DETECTION. 3. NAVIGATED TO THE RUNTIME SETTINGS SECTION. 4. UPDATED THE JAVA VERSION TO JDK 17. 5. SAVED THE CHANGES AND DEPLOY THE UPDATED CONFIGURATION. 6. TESTED THE LAMBDA FUNCTION TO ENSURE IT'S WORKING CORRECTLY WITH THE NEW JAVA VERSION. 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL REVIEW OF THE EVENT AND/OR ADDITIONAL INFORMATION RECEIVED SHOWS THAT THERE IS NO INFORMATION TO REASONABLY SUGGEST THAT THE DEVICE IN THIS REPORT MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE IN THIS REPORT HAS MALFUNCTIONED. THEREFORE, THIS EVENT DID NOT AND DOES NOT MEET THE REPORTING REQUIREMENTS STIPULATED IN 21 CFR 803. 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 CGM VALUE UNAVALIABLE. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-8061. TROUBLESHOOTING WAS PERFORMED. IT WAS UNABLE TO RESOLVE THE COMMUNICATION ISSUE BY FORCE CLOSING AND RE-LAUNCHING INPEN APP, THE ISSUE WAS ESCALATED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. NO PRODUCT RETURN IS REQUIRED FOR MMT-8061.

    Description of Event or Problem · 0

    DOWNGRADING THE CASE TO NON-REPORTABLE AS THE INITIAL REPORT WAS SUBMITTED IN ERROR. AS PER THE CASE NOTES, THE INPEN APP WAS NOT REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776927 SFTWR MMT-8061 INPEN APP ANDROID CALCULATOR, DRUG DOSE NDC COMPANION MEDICAL INC MMT-8061

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Unknown