BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTPHONE ANDROID APP: PUMP CONNECT

    MDR report key: 18204323 · Received November 24, 2023

    Report

    Report Number
    2032227-2023-309069
    Event Type
    Malfunction
    Date Received
    November 24, 2023
    Date of Event
    September 12, 2023
    Report Date
    December 19, 2023
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    PKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL REVIEW OF THE EVENT AND/OR ADDITIONAL INFORMATION RECEIVED SHOWS THAT THERE IS NO INFORMATION TO REASONABLY SUGGEST THAT THE DEVICE IN THIS REPORT MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE IN THIS REPORT HAS MALFUNCTIONED. THEREFORE, THIS EVENT DID NOT AND DOES NOT MEET THE REPORTING REQUIREMENTS STIPULATED IN 21 CFR 803.

    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. MAKE SURE THAT THE PHONE AND PUMP ARE NEXT TO EACH OTHER DURING THE PROCESS REMIND THE CUSTOMER THAT THE UPLOADS COULD LAST FOR 2 HOURS. IF CUSTOMER HAS RECENTLY UPDATED THE PUMP TO 780G, DELETE THE UPDATER APPLICATION FROM THE PHONE. DELETE AND REINSTALL THE MINIMED MOBILE APPLICATION. ENSURE BOTH THE PHONE AND PUMP DO NOT HAVE ANY PAIRINGS. MAKE SURE THAT THERE ARE NO OTHER APPS WHICH USING A BLUETOOTH CONNECTION ON PHONE. UNPAIR AND REPAIRING PUMP AND APP. SET MMM APP BATTERY USAGE TO UNRESTRICTED. TURN OFF POWER SAVING. DEFINE MMM APP AS A NEVER-SLEEP APP. SWITCH ADAPTIVE BATTERY TO OFF. RESET NETWORK SETTINGS. CLEAR BLUETOOTH CACHE. IF THE PREVIOUS STEPS HAVE FAILED, PLEASE WALK CUSTOMER THROUGH UPLOADING SNAPSHOTS THROUGH A PC. THERE HAVE BEEN REPORTS THAT¿S UPLOADING SNAPSHOTS THROUGH THE PC HAS RESOLVED THE ISSUE ON THE MMM APP. WE HAVE RECEIVED FEEDBACK FROM THE HELPLINE REGARDING THE RESULTS OF THE RESOLUTION STEPS. THEY HAVE VERIFIED THAT THESE STEPS WERE EFFECTIVE IN CERTAIN CASES. 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

    UPDATED INFO: THE CUSTOMER HAVE A GENERAL PRODUCT QUESTION OR POSSIBLE ALLEGATION NOT COVERED IN EXISTING TROUBLESHOOTING. THE CASE IS NON-REPORTABLE PER REPORTABILITY DECISION TOOL.

    Description of Event or Problem · 0

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER WAS NOT ABLE TO UPLOAD TO CARELINK PERSONAL. TROUBLESHOOTING WAS PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL NOT BE RETURNED FOR FAILURE ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1499436 SMARTPHONE ANDROID APP: PUMP CONNECT INSULIN PUMP SECONDARY DISPLAY PKU MEDTRONIC MINIMED MMT-6101

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Unknown