BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SFTWR MMT-8060 INPEN APP IOS

    MDR report key: 23141354 · Received September 25, 2025

    Report

    Report Number
    3012822846-2025-01088
    Event Type
    Malfunction
    Date Received
    September 25, 2025
    Date of Event
    August 6, 2025
    Report Date
    October 18, 2025
    Manufacturer
    COMPANION MEDICAL INC
    Product Code
    NDC
    PMA / PMN Number
    K201337
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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. 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 INPEN 2.0 IOS AND ANDROID APP(S) V8.0.0 WITH INPEN US CLOUD VERSION 8.0.0 WAS CONDUCTED AND CONFIRMED THE ISSUE(S) IS/ARE REPRODUCIBLE. THIS ISSUE IS CONFIRMED. THE SOFTWARE SUCCESSFULLY ADHERED TO THE SPECIFIED REQUIREMENTS AND PERFORMED IN ACCORDANCE WITH EXPECTATIONS AS REFERENCED IN OUS SWR0091901 (APP VERSION 7.5.0.32) US SWR00086 APP VERSION 5.7.1.4. THE CUSTOMER APPEARS TO HAVE BEEN AFFECTED BY ONE OF THE SYMPTOMS ATTRIBUTED TO GOOGLE RATE LIMITING. THIS ISSUE CAN CAUSE VARIOUS PROBLEMS SUCH AS, 1) ABILITY TO FETCH REPORTS FROM INPEN, 2) ACCESS TO THE CONNECTION SCREEN WITHOUT THE BUTTON DISAPPEARING, 3) NO NO INTERNET CONNECTION OR ANY OTHER SERVER ERROR MESSAGES, 4) DATA SYNCING PROPERLY AS EXPECTED, 5) VALUES DISPLAYING CORRECTLY (NO LONGER SHOWING). AFTER CONDUCTING A THOROUGH INVESTIGATION, WE FOUND THAT GOOGLE WAS INSTITUTING RATE LIMITING ON THE USE OF APPENGINE BY INPEN CLOUD IN BOTH US, FIRST, AND OUS, LATER, AS WELL, WHICH GOOGLE LATER CONFIRMED WAS DUE TO ACCOUNTING / BILLING ISSUE(S) THAT REMAIN OUTSTANDING. AN INPEN PROBLEM REPORT (B)(4) WAS CREATED FOR CLOUDCLOUD COMPONENTSUSOUS GCP APPENGINE INSTANCE MIGRATION WARMUP FAILURES (RATE LIMITING) AND HAS BEEN ADDRESSED ACCORDINGLY. TO ASSIST WITH THE RESOLUTION OF THE ISSUE, WE PROVIDED THE HELPLINE TEAM WITH AN ADVISORY OF THE SITUATION AND UPDATES; ACCORDINGLY, TECH SUPPORT THEN BEGAN TAGGING SUSPECTED GOOGLE RATE LIMITING ISSUES WITH LABEL INPENGCPRATELIMITING. THE ISSUE HAS BEEN ADDRESSED THROUGH A CONFIGURATION BY GOOGLE TO SPECIFY THE TOTAL FRONTEND LOGICAL INSTANCE COUNT QUOTA IS NOW 20,000 (20K) HAVING PREVIOUSLY BEING 40,000 (40K) PRIOR TO THE RATE LIMITING AT 20 (.02K) ON OR ABOUT (B)(6) 2025 IN BOTH PRODUS AND PRODEU ENVIRONMENTS. MEDTRONIC WILL WORK SEPARATELY TO RESOLVE ANY OUTSTANDING BILLING / ACCOUNTING ISSUES PRIOR TO (B)(6) 2025. WE HAVE INFORMED HELPLINE TO PLEASE CHECK WITH THE CUSTOMER TO SEE IF ISSUE IS NOW RESOLVED, AND IF ISSUE IS STILL OBSERVED, TO PLEASE EXPECT ISSUES TO SUBSIDE IN A FEW DAYS AS THE SYSTEM CATCHES UP FULLY. 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 A COMMUNICATION ISSUE BETWEEN INPEN APPLICATION AND CONTINUOUS GLUCOSE MONITORING SYSTEM AS THE GLUCOSE DATA WAS NOT DISPLAY IN THE INPEN APPLICATION. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-8060. TROUBLESHOOTING WAS PERFORMED AND IT WAS UNABLE TO RESOLVE WITH EXISTING TROUBLESHOOTING OR LABELED INSTRUCTIONS, ISSUE ESCALATED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. A PRODUCT RETURN IS NOT APPLICABLE FOR NON PHYSICAL DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1824992 SFTWR MMT-8060 INPEN APP IOS CALCULATOR, DRUG DOSE NDC COMPANION MEDICAL INC MMT-8060

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female