BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTPHONE ANDROID APP: PUMP CONNECT

    MDR report key: 17819680 · Received September 26, 2023

    Report

    Report Number
    2032227-2023-274725
    Event Type
    Malfunction
    Date Received
    September 26, 2023
    Date of Event
    August 31, 2023
    Report Date
    November 13, 2023
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    PKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER UNABLE TO PAIR - HUAWEI MATE 20 PRO, LYA-L29, 2.1.0, EMUI 12. "AN ATTEMPT TO REPRODUCE THE REPORTED EVENT WITH MINIMED MOBILE APP (SOFTWARE VERSION 2.1.0) INSTALLED ON HUAWEI MATE 20 PRO (ANDROID 10, EMUI 11) WITH MMT-1885 780G PUMP (SOFTWARE VERSION 6.7V.3) 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 SOFTWARE REQUIREMENT AND SPECIFICATION DOCUMENT: (B)(4). BASED ON OUR INITIAL COMPREHENSIVE INVESTIGATION, WE HAVE DETERMINED THAT THE THREE FAILED PAIRING ATTEMPTS WERE ATTRIBUTED TO THE SUPERVISOR_TIMEOUT ERROR RETURNED BY THE ANDROID OS, WITH TWO OF THESE CASES BEING SPECIFICALLY LINKED TO (B)(4). FURTHER IN-DEPTH INVESTIGATION REVEALED THAT THE ROOT CAUSE FOR THE TWO SUBSEQUENT PAIRING ATTEMPTS WAS ALSO THE SUPERVISOR_TIMEOUT ERROR FROM THE ANDROID OS, AND ALL OF THESE CASES WERE ATTRIBUTED TO (B)(4). APP PERFORMED AS EXPECTED PER SPECIFICATION (BLE CONNECT MOBILE APPLICATION AND PUMP SPID, (B)(4)). HOWEVER THE REQUIREMENT, (B)(4) WAS NOT WORKING AS EXPECTED SINCE PUMP DESIGN SPECIFICATION, (B)(4) WAS NOT MET. APP BEHAVES AS EXPECTED: SUPERVISOR TIMEOUT CASES WERE CONSIDERED AS CONNECTIONS TO BE LOST AFTER DISCONNECTION APP PERFORMED AUTO RECONNECT ATTEMPTS ALL LOST BONDING CASES WERE CONSIDERED AS LOSS OF ASSOCIATION WITH THE PUMP (SO THAT NO FURTHER RECONNECT ATTEMPTS OCCUR) THE ESF NUMBER THAT CORRESPONDS TO THE REPORTED ISSUE IS (B)(4). THE ROOT CAUSE OF THE ISSUE IS RELATED TO PUMP BEHAVIOR WHICH IS RECORDED UNDER THIS ESF. THIS SOFTWARE ANOMALY WAS OBSERVED FOR HUAWEI PHONES WHICH WERE UPDATED TO EMUI 12+. THERE ARE SOME CHANGES THAT CAUSE AN ERROR IN THE PUMP PAIRING PROCESS. TO ASSIST WITH THE RESOLUTION OF THE ISSUE, INITIALLY WE PROVIDED THE HELPLINE TEAM WITH THE FOLLOWING WORKAROUND TO ENSURE THAT IT IS ADDRESSED EFFECTIVELY: UPDATE THE EMUI OS VERSION. WAIT FOR A FIX FROM HUAWEI DEVELOPERS. 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 RECEIVED A DEVICE NOT FOUND ALERT DURING THE PUMP PAIRING PROCESS AND WAS UNABLE TO PAIR THE MINIMED MOBILE APPLICATION TO THE INSULIN PUMP. TROUBLESHOOTING WAS PERFORMED AND THE CUSTOMER WAS TO DELETE PUMP SETTINGS AND BLUETOOTH SETTINGS TURN-OFF AND TURN-ON. THE CUSTOMER WAS TO FORCE CLOSE AND RE-LAUNCH THE APPLICATION; HOWEVER, THE ISSUE WAS NOT RESOLVED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER CONTINUED THE USE OF THE APPLICATION, AND IT WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1019676 SMARTPHONE ANDROID APP: PUMP CONNECT INSULIN PUMP SECONDARY DISPLAY PKU MEDTRONIC MINIMED MMT-6101

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Unknown