BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTPHONE IOS APP: PUMP CONNECT

    MDR report key: 15720215 · Received November 3, 2022

    Report

    Report Number
    2032227-2022-353380
    Event Type
    Malfunction
    Date Received
    November 3, 2022
    Date of Event
    September 26, 2022
    Report Date
    March 27, 2023
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    PKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SEVERAL ATTEMPTS TO REPRODUCE THE ISSUE ON APP VERSION 1.3.1 USING DIFFERENT CONFIGURATIONS WERE MADE, AND THE ISSUE WAS REPRODUCED. CONFIGURATIONS USED: IPHONE XS MAX (IOS 16.0.2) + PUMP 770G (SW 5.3); IPHONE XS MAX (IOS 16.0.3) + PUMP 780 G (SW 6.7U) + SIMULATED SENSOR. UNFORTUNATELY, APP LOGS WERE NOT ENOUGH TO IDENTIFY THE ROOT CAUSE OF THE ISSUE. MOST LIKELY THE ISSUE IS THAT WRONG SAKE KEYS ARE COMMUNICATED FROM OUR INTERNAL STORAGE AND SEND THEM TO THE PUMP. AS THE SAKE KEYS ARE INCORRECT, THE PUMP CUTS THE CONNECTION AND UNPAIRS THE PHONE. MORE DETAILS REGARDING THIS ISSUE CAN BE FOUND IN ESF 4766848. FURTHER IT CAN BE CONCLUDED THAT IOS CAN KILL AN APPLICATION IF THE RESOURCES ARE NEEDED FOR OTHER APPS. IN OUR CASE SUCH BEHAVIOR LEADS TO ISSUES GETTING SAKE KEYS FROM THE KEYCHAIN. THE WORKAROUND FOR THE ISSUE WAS SUGGESTED TO RE-PAIR THE PHONE EACH TIME WHEN THE PAIRING WAS LOST. THE SOFTWARE DID NOT PERFORMED AS EXPECTED PER SPECIFICATION - BLE CONNECT IOS AND ANDROID MOBILE SOFTWARE REQUIREMENTS SPECIFICATIONS, D00780504. 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 EVERY MORNING HE HAS TO RE-PAIR MOBILE AND PUMP. THE TROUBLESHOOTING WAS PERFORMED AND THE ISSUE WAS NOT RESOLVED. IT IS UNKNOWN IF THE CUSTOMER HAD CONTINUED TO USE THE DEVICE. THE DEVICE WILL NOT BE RETURNED FOR THE PRODUCT ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509469 SMARTPHONE IOS APP: PUMP CONNECT INSULIN PUMP SECONDARY DISPLAY PKU MEDTRONIC MINIMED MMT-6102

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown