BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK PRO ONLINE

    MDR report key: 17477537 · Received August 8, 2023

    Report

    Report Number
    2032227-2023-250261
    Event Type
    Malfunction
    Date Received
    August 8, 2023
    Date of Event
    July 19, 2023
    Report Date
    September 27, 2023
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    PHV
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION/TESTING SUMMARY: AN ATTEMPT TO REPRODUCE THE REPORTED EVENT USING CARELINK SYSTEM 3.9A ON DELL PRECISION 7560 MICROSOFT WINDOWS 11 ENTERPRISE (10.0.22621 BUILD 22621) WAS CONDUCTED AND CONFIRMED THE ISSUE IS NOT REPRODUCED. ATTEMPTED TO REPRODUCE THE ISSUE 3 TIMES. (MOST LIKELY) ROOT CAUSE: AFTER CONDUCTING A THOROUGH INVESTIGATION, WE HAVE CONFIRMED THROUGH INFRASTRUCTURE TEAMS THAT THERE WAS A REPORTED SERVICE INTERRUPTION DURING THE TIME FRAME THAT MEDTRONIC FIELD REPRESENTATIVE REPORTED ISSUE. ANALYSIS SUMMARY: THE CARELINK SUPPORT TEAM IDENTIFIED THAT THERE WAS A REPORTED OUTAGE OF THE FIELDCAST SERVICE USED TO GENERATE CLINIC REGISTRATION CODES DURING THE TIME FRAME ISSUE WAS REPORTED. THE FOLLOWING STEPS TO RESOLVE THE ISSUE WERE PROVIDED TO THE TECHNICAL SUPPORT: - THERE WAS AN OUTAGE THAT AFFECTED A SYSTEM RELATED TO THIS ISSUE. COULD WE ASK THE REP TO TEST ONCE MORE TO CONFIRM. THE HELPLINE HAS PROVIDED US WITH FEEDBACK REGARDING THE OUTCOME OF THE RESOLUTION STEPS IMPLEMENTED AND HAS CONFIRMED THE ISSUE HAS BEEN SUCCESSFULLY RESOLVED. 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. 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 TRIED TO SET UP A NEW CARELINK PRO ACCOUNT AND GOT THE FAILED REGISTRATION CODE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. TROUBLESHOOTING WAS PERFORMED, IT WAS UNKNOWN WHETHER THE CUSTOMER TO CONTINUE TO USE THE APP AND WHICH WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1466890 CARELINK PRO ONLINE CONTINUOUS GLUCOSE MONITOR RETROSPECTIVE DATA ANALYSIS SOFTWARE PHV MEDTRONIC MINIMED MMT-7350

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown