BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTWARE MMT-7335 CD-ROM CARELINK PRO EN

    MDR report key: 17036631 · Received June 1, 2023

    Report

    Report Number
    2032227-2023-211905
    Event Type
    Malfunction
    Date Received
    June 1, 2023
    Date of Event
    February 22, 2023
    Report Date
    September 22, 2023
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P150001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL MDT REPRESENTATIVE COMMUNICATED THAT THEY WERE FACING CONCERNS ABOUT PARADIGM AND 640G PUMPS NOT WORKING WITH CARELINK. "COMPLAINT SUMMARY: INTERNAL MDT REPRESENTATIVE COMMUNICATED THAT THEY WERE FACING CONCERNS ABOUT PARADIGM AND 640G PUMPS NOT WORKING WITH CARELINK. INVESTIGATION/TESTING SUMMARY: INVESTIGATED CARELINK DATABASE APPLICATION LOGS FOR FAILED UPLOADS FROM AFFECTED PUMPS. CONFIRMED UPLOADS FAILURES. SUPPORT TEAM COULD NOT REPRODUCE ISSUE SO INVOLVED TEST AND DEVELOPMENT TEAMS TO ASSIST WITH THE INVESTIGATION. CARELINK TEAM CREATED A TICKET POW-3972 FOR THE TEST/DEV TEAM TO INVESTIGATE. AFTER CONDUCTING A THOROUGH INVESTIGATION, IT WAS CONFIRMED THAT CODE UPDATES WOULD BE REQUIRED IN A FUTURE RELEASE TO ENSURE SUPPORT FOR AFFECTED PUMP MODELS. THE ESF NUMBER THAT CORRESPONDS TO THE REPORTED ISSUE IS: (B)(4). THE SOFTWARE DID SUCCESSFULLY ADHERED TO THE SPECIFIED REQUIREMENTS AND PERFORMED IN ACCORDANCE WITH THE EXPECTATIONS SPECIFIED IN THE PCH0084673, BUT DUE TO INTERNAL LEGAL DATA PRIVACY CONSTRAINTS, AN INFRASTRUCTURE CHANGE WAS REQUIRED. (MOST LIKELY) ROOT CAUSE: THE CAUSE WAS DETERMINED TO BE AN INCOMPATIBILITY WITH CARELINK OF CERTAIN OLDER PUMP MODELS BY TEST, DEVELOPMENT, AND SUPPORT TEAMS. ANALYSIS SUMMARY: AFTER INVESTIGATION BY DEVELOPMENT, TEST AND SUPPORT TEAMS IT WAS DETERMINED THAT CARELINK WOULD NEED TO BE UPDATED TO ENSURE CONTINUED SUPPORT FOR PUMP MODELS. DEVS CONFIRMED THAT A FIX IS TO BE RELEASED IN VERSION 3.9.0 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. 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 RECEIVED A SERVER ERROR AND THE "UNLOAD DATA FROM THE PUMP" BUTTON IS PUSHED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. TROUBLESHOOTING WAS NOT PERFORMED AND FOUND THAT THE ISSUE WAS NOT RESOLVED. THE CUSTOMER WILL CONTINUE TO USE THE DEVICE AND IT WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1830435 SOFTWARE MMT-7335 CD-ROM CARELINK PRO EN SENSOR, GLUCOSE, INVASIVE MDS MEDTRONIC MINIMED MMT-7335

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown