BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK PERSONAL MMT-7333

    MDR report key: 18089877 · Received November 8, 2023

    Report

    Report Number
    2032227-2023-299091
    Event Type
    Malfunction
    Date Received
    November 8, 2023
    Date of Event
    August 28, 2023
    Report Date
    January 19, 2024
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P150001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    HELPLINE SUPPORT TEAM REPORTED THAT THE USER THERE IS A DISCREPANCY OVER THE SAME SELECTED PERIOD FOR DTQ , BASAL AND BOLUS VALUE BETWEEN PUMP DATA AND CARELINK REPORTS "COMPLAINT SUMMARY: HELPLINE SUPPORT TEAM REPORTED THAT THE USER THERE IS A DISCREPANCY OVER THE SAME SELECTED PERIOD FOR DTQ , BASAL AND BOLUS VALUE BETWEEN PUMP DATA AND CARELINK REPORTS INVESTIGATION/TESTING SUMMARY: AN ATTEMPT WAS MADE TO REPRODUCE THE ISSUE BY GENERATING THE REPORTS FOR THE PROVIDED USER IN CARELINK SUPPORT APPLICATION AND CONFIRMED THAT THE ISSUE IS NOT REPRODUCIBLE. HOWEVER TO FURTHER ANALYSIS RAISED AN INTERNAL JIRA TICKET TO CARELINK DEVELOPMENT TEAM TO UNDERSTAND THE SYSTEM REQUIREMENT. CARELINK DEVELOPMENT TEAM PROVIDE THE BELOW FEEDBACK AND CONFIRMED THAT THIS IS EXPECTED SYSTEM BEHAVIOR. ""THE DISCREPANCY OVER THE SAME SELECTED PERIOD FOR THE PUMP AND CARELINK REPORT IS BECAUSE THE LAST DAY OF THE UPLOAD WAS TAKEN AS THE PARTIAL DAY BY CARELINK. THIS IS BECAUSE THE TOTAL DAILY DOSE WAS NOT PROVIDED BY THE PUMP,. THE TOTAL DAILY DOSE IS OBTAINED ONLY AT END OF DAY. HENCE CARELINK CONSIDERED 13 DAYS PERIOD VS PUMP CONSIDERS 14 DAYS PERIOD. A&P REPORT WITH 14 DAYS AND THE LAST DAY OF THE UPLOAD IS CONSIDERED AS PARTIAL DAY "" THE SOFTWARE SUCCESSFULLY ADHERED TO THE SPECIFIED REQUIREMENTS AND PERFORMED IN ACCORDANCE WITH THE EXPECTATIONS SPECIFIED IN THE SOFTWARE REQUIREMENT AND SPECIFICATION DOCUMENT LISTED BELOW UNDER ""SW REQUIREMENT DOC. (MOST LIKELY) ROOT CAUSE: THIS IS NOT AN ISSUE RATHER ITS AN EXISTING SYSTEM BEHAVIOR WHERE THE TOTAL DAILY DOSE CALCULATION IS DIFFERENT FROM PUMP AND CARELINK REPORTS ANALYSIS SUMMARY: PROVIDED THE FEEDBACK FROM CARELINK DEVELOPMENT TEAM TO HELPLINE SUPPORT TEAM. DESPITE OF FOLLOWS , WE WERE UNABLE TO OBTAIN RESPONSE FROM THE HELPLINE TEAM 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 HAS REPORTED A MISMATCH BETWEEN CARELINK AND INSULIN PUMP DISPLAYS. TROUBLESHOOTING WAS NOT PERFORMED AND THE ISSUE WAS NOT RESOLVED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL CONTINUE USING THE APPLICATION AND THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1277580 CARELINK PERSONAL MMT-7333 SENSOR, GLUCOSE, INVASIVE MDS MEDTRONIC MINIMED MMT-7333

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown