BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTWARE, PRAAS VERSION 2.0A

    MDR report key: 19603999 · Received June 25, 2024

    Report

    Report Number
    2032227-2024-191672
    Event Type
    Malfunction
    Date Received
    June 25, 2024
    Date of Event
    June 7, 2024
    Report Date
    July 15, 2024
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    PHV
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT SUMMARY: HELPLINE SUPPORT TEAM REPORTED THAT THE USER WAS UNABLE TO GENERATE DATA ANY REPORTS IN CARELINK PERSONAL APPLICATION. INVESTIGATION/TESTING SUMMARY: AN ATTEMPT WAS MADE TO REPRODUCE THE ISSUE BY GENERATING REPORTS FOR THE CARELINK PERSONAL USER IN THE CARELINK SUPPORT APPLICATION AND CONFIRMED THAT THE ISSUE WAS REPRODUCIBLE. IDENTIFIED THAT THE PATIENT RECORD HAD TIME OVERLAP BETWEEN THE MEAL PERIODS WITHIN THEIR ""PREFERENCES"" SETTINGS. TO AID IN RESOLVING THE ISSUE, WE HAVE NOTIFIED THE HELPLINE REGARDING THE FOLLOWING STEPS: -THERE IS AN OVERLAP BETWEEN THE BREAKFAST AND OVERNIGHT MEAL PERIODS. THERE WAS A 1 HOUR OF OVERLAPPING TIME SET BETWEEN OVERNIGHT MEAL AND BREAKFAST MEAL PERIOD, CAUSING THE PREFERENCE OVERLAP. THEREFORE, THERE SHOULD BE NO OVERLAPPING TIME BETWEEN EACH MEAL PERIOD. THE SOFTWARE SUCCESSFULLY ADHERED TO THE SPECIFIED REQUIREMENTS AND PERFORMED IN ACCORDANCE WITH THE EXPECTATIONS SPECIFIED IN THE SOFTWARE REQUIREMENT AND SPECIFICATION IN ""SW REQUIREMENT DOC"" LISTED BELOW. (MOST LIKELY) ROOT CAUSE: THE ROOT CAUSE OF THE ISSUE WAS IDENTIFIED AS OVERLAPPING MEAL PERIOD PREFERENCES, WHICH RESULTED IN THE REPORTED PROBLEM. ANALYSIS SUMMARY: REQUESTED HELPLINE SUPPORT TEAM TO INFORM USER TO UPDATE THE OVERLAPPING MEAL PERIOD RANGE IN ACCOUNT SETTINGS AND TRY TO GENERATE REPORTS. HELPLINE CONFIRMED THAT AFTER UPDATING THE MEAL PERIOD OVERLAP ISSUE WAS RESOLVED. 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 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.

    Description of Event or Problem · 0

    IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED REPORT ANOMALY. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) ACC-7333. UNABLE TO RESOLVE WITH EXISTING TROUBLESHOOTING OR LABELED INSTRUCTIONS, ISSUE ESCALATED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. NO PRODUCT RETURN IS REQUIRED FOR ACC-7333.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208600 SOFTWARE, PRAAS VERSION 2.0A CONTINUOUS GLUCOSE MONITOR RETROSPECTIVE DATA ANALYSIS SOFTWARE PHV MEDTRONIC MINIMED ACC-7333

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown