BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTPHONE ANDROID APP: PUMP CONNECT

    MDR report key: 17468168 · Received August 7, 2023

    Report

    Report Number
    2032227-2023-249758
    Event Type
    Malfunction
    Date Received
    August 7, 2023
    Date of Event
    July 17, 2023
    Report Date
    November 14, 2023
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    PKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    FB36AF CONFIGURATION ISSUE CUSTOMER CANNOT LOGIN TO MMM (SAMSUNG GALAXY S20 FE, ANDROID 12, APP VERSION 1.3.2) "AN ATTEMPT TO REPRODUCE THE REPORTED EVENT WITH MINIMED MOBILE APP (SOFTWARE VERSION 2.1.0) INSTALLED ON SAMSUNG GALAXY S21 (ANDROID 12) WITH MMT-1880 770G PUMP (SOFTWARE VERSION 5.2A) WAS CONDUCTED AND CONFIRMED THE ISSUE WAS NOT REPRODUCED. THE SOFTWARE SUCCESSFULLY ADHERED TO THE SPECIFIED REQUIREMENTS AND PERFORMED IN ACCORDANCE WITH THE EXPECTATIONS SPECIFIED IN THE CARELINK SPID (B)(4) VERSION G. WE WERE UNABLE TO CONDUCT A THOROUGH INVESTIGATION DUE TO LACK OF DIAGNOSTIC LOGS NECESSARY TO PERFORM A COMPREHENSIVE ANALYSIS. WITHOUT ACCESS TO THE REQUIRED DATA, WE ARE UNABLE TO IDENTIFY A DEFINITIVE ROOT CAUSE OF THE ISSUE. MOST LIKELY THE ISSUE WAS ON CARELINK SIDE (HAPPENING DURING RECENT CARELINK OUTAGE). 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. 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 REPORTED THAT THE USERNAME OR PASSWORD WAS INCORRECT BUT IT WAS CORRECT, CUSTOMER WAS ABLE TO LOG IN CARELINK PERSONAL PAGE BUT NOT MOBILE APPLICATION. TRIED TO UNPAIR AND PAIR AGAIN - BUT ISSUE WAS NOT RESOLVED. MORE OVER DATA WAS VISIBLE NOW, BUT STILL NOT ABLE TO SENT DATA TO CARELINK PERSONAL. NOT POSSIBLE TO UPLOAD DATA TO CARELINK. TROUBLESHOOTING WAS NOT PERFORMED AND THE ISSUE WAS UNABLE TO RESOLVE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL CONTINUE USING THE APPLICATION. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1223283 SMARTPHONE ANDROID APP: PUMP CONNECT INSULIN PUMP SECONDARY DISPLAY PKU MEDTRONIC MINIMED MMT-6101

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Unknown