BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK PERSONAL MMT-7333

    MDR report key: 17736871 · Received September 13, 2023

    Report

    Report Number
    2032227-2023-271539
    Event Type
    Malfunction
    Date Received
    September 13, 2023
    Date of Event
    August 24, 2023
    Report Date
    October 25, 2023
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P150001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    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, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Additional Manufacturer Narrative · 0

    USER REPORTED SEEING ERROR MESSAGE STATING "APP HAS BEEN BLOCKED FOR YOUR PROTECTION" WHEN TRYING TO INSTALL CARELINK UPLOADER. "COMPLAINT SUMMARY: USER REPORTED SEEING ERROR MESSAGE STATING ""APP HAS BEEN BLOCKED FOR YOUR PROTECTION"" WHEN TRYING TO INSTALL CARELINK UPLOADER. INVESTIGATION/TESTING SUMMARY: AN ATTEMPT TO REPRODUCE THE REPORTED EVENT USING CARELINK UPLOADER 3.5-3.9 INSTALLED ON DELL PRECISION 7560 WINDOWS 11 WAS CONDUCTED AND CONFIRMED THE ISSUE IS REPRODUCED. ATTEMPTED 5 TIMES. NO LOGS WERE NECESSARY FOR INVESTIGATION. AS ERROR MESSAGE PROVIDED ROOT CAUSE OF FAULT. SECURITY CERTIFICATE HAD BEEN INVALIDATED BY MICROSOFT. NEW CERTIFICATE WAS GENERATED, PACKAGED WITH APPLICATION AND MADE AVAILABLE FOR DOWNLOAD. SUPPLIED HELPLINE AND CUSTOMER WITH THE FOLLOWING TROUBLESHOOTING STEPS: WAIT UNTIL REPACKAGED APPLICATION WAS AVAILABLE THEN DOWNLOAD AND INSTALL. THE SOFTWARE SUCCESSFULLY ADHERED TO THE SPECIFIED REQUIREMENTS AND PERFORMED IN ACCORDANCE WITH THE EXPECTATIONS SPECIFIED IN THE 10542712DOC_X, VERSION PCH00098029. (MOST LIKELY) ROOT CAUSE: MICROSOFT/DIGICERT INVALIDATED THE SECURITY CERTIFICATE GRANTED TO MEDTRONIC FOR USE IN CARELINK UPLOADER. ANALYSIS SUMMARY: MICROSOFT/DIGICERT INVALIDATED THE SECURITY CERTIFICATE GRANTED TO MEDTRONIC FOR USE IN CARELINK UPLOADER. UPLOADER DEVELOPMENT TEAM WAS NOTIFIED. THEY GENERATED A NEW SECURITY CERTIFICATE AND REPACKAGED THE APPLICATION AND MADE IT AVAILABLE FOR DOWNLOAD. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Description of Event or Problem · 0

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER REPORTED THAT WAS UNABLE TO UPLOAD AND THE UPLOADER WAS BLOCKED. TROUBLESHOOTING WAS PERFORMED AND THE UPLOADER WAS BLOCKED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER CONTINUED USING THE APPLICATION AND IT WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84009 CARELINK PERSONAL MMT-7333 SENSOR, GLUCOSE, INVASIVE MDS MEDTRONIC MINIMED MMT-7333

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown