BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK PERSONAL MMT-7333

    MDR report key: 17622651 · Received August 25, 2023

    Report

    Report Number
    2032227-2023-261796
    Event Type
    Malfunction
    Date Received
    August 25, 2023
    Date of Event
    August 7, 2023
    Report Date
    November 23, 2023
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P150001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    USER REPORTED BEING UNABLE TO UPLOAD PUMP DATA WITH THEIR METER. "COMPLAINT SUMMARY: USER REPORTED BEING UNABLE TO UPLOAD PUMP DATA WITH THEIR METER. INVESTIGATION/TESTING SUMMARY: AFTER CONDUCTING A THOROUGH INVESTIGATION, IT WAS DETERMINED THAT THE PROBLEM STEMMED FROM CONTOUR NEXTLINK DRIVER ISSUES AND DISCREPANCIES IN TIME SETTINGS. WE DID NOT NEED TO PERFORM ADDITIONAL TESTING FOR THIS MATTER, AS THE DATA OBTAINED FROM THE CARELINK UPLOADER APPLICATION LOGS CONFIRMED THE SAME ISSUE. WE SUPPLIED HELPLINE AND CUSTOMER WITH THE FOLLOWING TROUBLESHOOTING STEPS: DID THE CUSTOMER RECENTLY CHANGE METERS? I SEE THAT ON AUG 4TH THEY ARE USING A CONTOUR NEXTLINK INTERNATIONAL THEN ON THE 7TH THEY ATTEMPT TO UPLOAD WITH A CONTOUR NEXTLINK PLUS 2 AND ALSO A CONTOUR NEXTLINK 2. THE LOGS SHOW ERRORS RELATED TO UPLOADER NOT BEING ABLE TO FIND THE METER IT IS EXPECTING. DESPITE MAKING ATTEMPTS TO CONTACT THE CUSTOMER TO ADDRESS THE ISSUE, THEY HAVE BEEN UNABLE TO OBTAIN A RESPONSE. THE SOFTWARE SUCCESSFULLY ADHERED TO THE SPECIFIED REQUIREMENTS AND PERFORMED IN ACCORDANCE WITH THE EXPECTATIONS SPECIFIED IN THE (B)(4). VERSION PCH00098029. (MOST LIKELY) ROOT CAUSE: DRIVER ISSUE WITH CONTOUR NEXTLINK METER ANALYSIS SUMMARY: THE ISSUE WAS CONTOUR NEXTLINK DRIVER ISSUES AND TIME DIFFERENCE ISSUES. 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. SELECT PATIENT INFORMATION CANNOT BE PROVIDED DUE TO REGIONAL PRIVACY REGULATIONS.

    Description of Event or Problem · 0

    THE CUSTOMER IS REPORTING BEING UNABLE TO UPLOAD DATA TO CARELINK, THEBG METER IS NOT DETECTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1055239 CARELINK PERSONAL MMT-7333 SENSOR, GLUCOSE, INVASIVE MDS MEDTRONIC MINIMED MMT-7333

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Unknown