BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTPHONE IOS APP: PUMP CONNECT

    MDR report key: 17403126 · Received July 27, 2023

    Report

    Report Number
    2032227-2023-243412
    Event Type
    Malfunction
    Date Received
    July 27, 2023
    Date of Event
    July 7, 2023
    Report Date
    October 15, 2023
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    PKU
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER REPORTED DIFFICULTY UPLOADING THROUGH CARELINK UPLOADER. "COMPLAINT SUMMARY: CUSTOMER REPORTED DIFFICULTY UPLOADING THROUGH CARELINK UPLOADER. INVESTIGATION/TESTING SUMMARY: AN ATTEMPT TO REPRODUCE THE REPORTED EVENT USING CARELINK UPLOADER 3.9.0 WAS NOT CONDUCTED. AS, PUMP MODEL INFORMATION WAS NOT SHARED OR AVAILABLE THROUGH LOGS. WE WERE UNABLE TO CONDUCT A THOROUGH INVESTIGATION DUE TO THERE BEING NO UPLOADER APPLICATION LOGS THAT COULD BE USED TO IDENTIFY A DEFINITIVE ROOT CAUSE OF THE ISSUE. TO ASSIST WITH THE RESOLUTION OF THE ISSUE, WE PROVIDED THE HELPLINE TEAM WITH TROUBLESHOOTING QUESTIONS: 1. IS THE CUSTOMER USING ANY SECURITY OR ANTI-VIRUS SOFTWARE? 2. DID THE CUSTOMER SEE ANY ERROR MESSAGES? WE HAVE MADE ATTEMPTS TO CONTACT THE CUSTOMER/REP TO ADDRESS THE ISSUE, BUT WE HAVE BEEN UNABLE TO OBTAIN A RESPONSE. THEREFORE, WE HAVE INFORMED THE HELPLINE TEAM MEMBER THAT WE ARE PROCEEDING TO CLOSE THIS ISSUE. IF THE ISSUE PERSISTS, KINDLY CREATE A NEW ONE AND WE WILL TAKE SWIFT AND EFFICIENT ACTION TO ADDRESS IT. (MOST LIKELY) ROOT CAUSE: BASED ON REPORTED ISSUE AND SIMILAR ISSUES CAUSE WAS MOST LIKELY A DRIVER INCOMPATIBILITY ISSUE. LIKELY DUE TO INCORRECT DRIVER BEING INSTALLED BY WINDOWS UPDATE. ANALYSIS SUMMARY: THE CARELINK SUPPORT TEAM DID NOT IDENTIFY CAUSE OF RESOLUTION OF ISSUE AS THERE WERE NO LOGS AVAILABLE AND TROUBLESHOOTING. 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 CARELINK CONNECT APP WAS UNRESPONSIVE. TROUBLESHOOTING WAS PERFORMED AND ADVISED THE CUSTOMER TO FORCE CLOSE AND RE-LAUNCH THE APPLICATION BUT THE ISSUE COULD NOT BE RESOLVED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. IT WAS UNKNOWN WHETHER THE CUSTOMER WILL CONTINUE THE USE OF THE DEVICE. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671616 SMARTPHONE IOS APP: PUMP CONNECT INSULIN PUMP SECONDARY DISPLAY PKU MEDTRONIC MINIMED MMT-6102

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Unknown