BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTWARE CSS7200 GRDN IOS APP

    MDR report key: 18361797 · Received December 20, 2023

    Report

    Report Number
    2032227-2023-318715
    Event Type
    Malfunction
    Date Received
    December 20, 2023
    Date of Event
    July 10, 2023
    Report Date
    August 20, 2024
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P160007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    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

    "AN ATTEMPT TO REPRODUCE THE REPORTED EVENT USING GUARDIAN SOFTWARE VERSION 1.3.2 INSTALLED ON IPHONE XS IOS 16.2 WITH A TRANSMITTER WAS CONDUCTED, AND CONFIRMED THE ISSUE IS REPRODUCIBLE. WE WERE ABLE TO REPRODUCE THE ISSUE 90% - 99% OF THE TIME DURING TESTING. THE SOFTWARE DID NOT SUCCESSFULLY ADHERE TO THE SPECIFIED REQUIREMENTS AND PERFORMED IN ACCORDANCE WITH THE EXPECTATIONS SPECIFIED IN THE SOFTWARE REQUIREMENTS SPECIFICATIONS ((B)(4)). AFTER CONDUCTING A THOROUGH INVESTIGATION, WE HAVE FOUND THAT THE UTILIZATION OF AN EXTRA-STRONG ZSHIELD CONFIGURATION DURING THE BUILD CREATION PROCESS HAS RESULTED IN PERFORMANCE ISSUES. SPECIFICALLY, THE COREANIMATION FUNCTIONALITY WITHIN THE NATIVE IOS SDK DOES NOT HAVE SUFFICIENT TIME TO EXECUTE ANIMATIONS ACCURATELY, CAUSING THE APPLICATION TO CRASH. TO RECTIFY THIS ISSUE, IT IS RECOMMENDED TO UPDATE THE ZSHIELD CONFIGURATION TO OPTIMIZE APP PERFORMANCE EFFECTIVELY. THE ESF NUMBER THAT CORRESPONDS TO THE REPORTED ISSUE IS: (B)(4). TO ASSIST WITH THE RESOLUTION OF THE ISSUE, WE PROVIDED THE HELPLINE TEAM WITH THE FOLLOWING WORK AROUND TO ENSURE THAT IT IS ADDRESSED EFFECTIVELY: 1. UPDATE THE GUARDIAN APP TO VERSION 1.3.3. AFC: SOFTWARE ANOMALY - FA21AF. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    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 GUARDIAN APPLICATION WAS UNRESPONSIVE. TROUBLESHOOTING WAS PERFORMED AND ADVISED TO CLOSE THE APPLICATION BY FORCE; HOWEVER, THE ISSUE WAS NOT RESOLVED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER CONTINUED USING THE APPLICATION AND IT WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1953802 SOFTWARE CSS7200 GRDN IOS APP SENSOR, GLUCOSE, INVASIVE MDS MEDTRONIC MINIMED CSS7200

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Unknown