BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK PRO ONLINE

    MDR report key: 18363402 · Received December 20, 2023

    Report

    Report Number
    2032227-2023-319296
    Event Type
    Malfunction
    Date Received
    December 20, 2023
    Date of Event
    November 27, 2023
    Report Date
    January 22, 2024
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    PHV
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    "COMPLAINT SUMMARY: USER REPORTED BEING DIFFICULTY WITH CARELINK UPLOADER PROXY SETUP. INVESTIGATION/TESTING SUMMARY: AN ATTEMPT TO REPRODUCE THE ISSUE WAS CONDUCTED ON DELL PRECISION 7560 ON WINDOWS 11 22H2 WITH CARELINK UPLOADER 3.10.0 AND 3.11.0. CONFIRMED ISSUE WAS NOT REPRODUCIBLE. CARELINK SUPPORT TEAM INVESTIGATED DATABASE APPLICATION LOGS AS WELL AS INSTALLATION LOGS PROVIDED BY HELPLINE/USER. CONFIRMED PROXY SETUP FAILURE ERRORS PRESENT THAT DESCRIBED DIFFICULTY REACHING USER'S PROXY SERVER. PROVIDED THE HELPLINE/USER THE FOLLOWING TROUBLESHOOTING STEPS: CLINIC NEEDS TO EITHER ENABLE ICMP PROTOCOL (PING USES ICMP PROTOCOL); DIRECTLY CONFIGURE PROXY BY MEANS OF PUTTING THE FOLLOWING ENTRIES IN C:\PROGRAM. FILES\MEDTRONIC\CARELINK\UPLOADER\DSS\JRE\LIB\NET.PROPERTIES: HTTPS.PROXYHOST=<IP ADDRESS> HTTPS.PROXYPORT=<PORT> THE SOFTWARE SUCCESSFULLY ADHERED TO THE SPECIFIED REQUIREMENTS AND PERFORMED IN ACCORDANCE WITH THE EXPECTATIONS SPECIFIED IN THE 10542712DOC_Y, VERSION PCH00104012. (MOST LIKELY) ROOT CAUSE: CAUSED BY USER'S LOCAL NETWORK CONFIGURATION. ICMP DISABLED. ANALYSIS SUMMARY: PROVIDED RESOLUTION STEPS TO HELPLINE. HELPLINE CONFIRMED THAT ISSUE HAD BEEN RESOLVED AND THAT ISSUE COULD BE CLOSED. 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

    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.

    Description of Event or Problem · 0

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER REPORTED INSTALLING THE NEW 3.10 UPLOADER BUT WAS NOT ABLE TO GET IT TO WORK. TROUBLESHOOTING WAS PERFORMED BUT THE ISSUE WAS NOT RESOLVED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. IT WAS UNKNOWN WHETHER THE CUSTOMER CONTINUED USING THE INSULIN PUMP AND THE DEVICE WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1957738 CARELINK PRO ONLINE CONTINUOUS GLUCOSE MONITOR RETROSPECTIVE DATA ANALYSIS SOFTWARE PHV MEDTRONIC MINIMED MMT-7350

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown