BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SFTWR MMT-6122 FOTA IOS OUS/US

    MDR report key: 17910229 · Received October 11, 2023

    Report

    Report Number
    2032227-2023-281770
    Event Type
    Malfunction
    Date Received
    October 11, 2023
    Date of Event
    September 16, 2023
    Report Date
    November 13, 2023
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OUG
    PMA / PMN Number
    P160017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    "AN ATTEMPT TO REPRODUCE THE REPORTED EVENT USING FOTA APP VERSION 1.3.4 INSTALLED ON IPHONE 11 (OS 17.0.2) WITH MMT-1884 PUMP (SOFTWARE VERSION 9.11.5) WAS CONDUCTED AND CONFIRMED THE ISSUE IS NOT REPRODUCED. ONE ATTEMPT WAS PERFORMED TO REPRODUCE THE ISSUE. THE SOFTWARE SUCCESSFULLY ADHERED TO THE SPECIFIED REQUIREMENTS AND PERFORMED IN ACCORDANCE WITH THE EXPECTATIONS SPECIFIED IN REQUIREMENT 3551323, 3551325 DOCUMENT (B)(4), VERSION G. WE WERE UNABLE TO CONDUCT A THOROUGH INVESTIGATION DUE TO MISSING THE CORRECT SERIAL NUMBER OF THE CUSTOMER'S PUMP AND APPLICATION LOGS WITH THE CASE DESCRIBED IN THE TICKET. WITHOUT ACCESS TO THE REQUIRED DATA, WE ARE UNABLE TO IDENTIFY A DEFINITIVE ROOT CAUSE OF THE ISSUE. IN THE TICKET DESCRIPTION AND ATTACHED LOGS, TWO DIFFERENT PUMP SERIAL NUMBERS WERE MENTIONED. HOWEVER, ONLY ONE PUMP WAS SUCCESSFULLY UPGRADED. THIS TICKET WAS CREATED FOR THE (B)(6), AND THIS PUMP HAS BEEN IN THE READY STATE SINCE (B)(4). THIS PUMP IS MISSING IN THE ATTACHED LOGS, AND IT SEEMS THE CUSTOMER DID NOT TRY TO UPDATE IT. AFTER THE LOGS INVESTIGATION, WE FOUND THAT THE CUSTOMER TRIED TO PAIR AND UPGRADE THE PUMP WITH SN (B)(6) WHICH IS ALREADY UPGRADED ACCORDING TO THE CIS IN CSD-4641. THE HELPLINE WAS ADVISED TO CONTACT THE CUSTOMER AND EXPLAIN THAT: 1) (B)(6) - READY FOR UPDATE SINCE SEP 10, 2) NG2488924H - SUCCESSFULLY UPGRADED ACCORDING TO THE CIS IN THE CSD-4641 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 REPORTED UPDATER APPLICATION, SHOWING NO UPDATE AVAILABLE. TROUBLESHOOTING WAS PERFORMED. THE ISSUE COULD NOT BE RESOLVED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. IT WAS UNKNOWN WHETHER THE CUSTOMER WILL CONTINUE USING THE DEVICE AND WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2164408 SFTWR MMT-6122 FOTA IOS OUS/US MEDICAL DEVICE DATA SYSTEM OUG MEDTRONIC MINIMED MMT-6122

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Male