BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK PRO ONLINE

    MDR report key: 20876489 · Received December 9, 2024

    Report

    Report Number
    2032227-2024-281729
    Event Type
    Malfunction
    Date Received
    December 9, 2024
    Date of Event
    November 12, 2024
    Report Date
    March 11, 2025
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    PHV
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN ATTEMPT TO REPRODUCE THE REPORTED EVENT PROCESSING SYSTEM WITH CURRENT PRODUCTION VERSION WAS CONDUCTED AND CONFIRMED THE ISSUE IS REPRODUCIBLE. THIS ISSUE IS CONFIRMED. THE SOFTWARE DID NOT ADHERE TO THE SPECIFIED REQUIREMENTS AND DID NOT PERFORM IN ACCORDANCE WITH THE EXPECTATIONS SPECIFIED IN THE RETINA SOFTWARE REQUIREMENT AND SPECIFICATION LISTED UNDER SW DOC FIELD. CURRENTLY, THE CARB RATIO KPI IS POPULATED BASED ON THE REQUIREMENT THAT CARB DATA IS ALWAYS IN THE GRAM UNIT. THE CARB UNIT CONVERSION IS PERFORMED ACCORDINGLY, AND THE KPI IS POPULATED IN BOTH GRAM AND EXCHANGE FORMATS. HOWEVER, WE OBSERVED THAT THE SNAPSHOT MAY CONTAIN CARB SETTING DATA IN EITHER GRAM OR EXCHANGE UNITS. DUE TO THIS, WHEN THE DATA IS PRESENT IN THE EXCHANGE FORMAT, RETINA IS INCORRECTLY INTERPRETING IT AS GRAM AND POPULATING THE KPIS, RESULTING IN DISCREPANCIES WITH THE PRAAS REPORT. 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 RECOMMENDATION TO ENSURE THAT IT IS ADDRESSED EFFECTIVELY: A FIX IS PLANNED FOR THE MAY RELEASE. 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

    SELECT PATIENT INFORMATION CANNOT BE PROVIDED DUE TO REGIONAL PRIVACY REGULATIONS. 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 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) MMT-7350. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER REPORTED INCORRECT SETTING OF BOLUS WIZARD, WHEN COPYING DATA FROM THE DASHBOARD. SETTING IN THE GENERATED PDF WERE DIFFERENT FROM THE COPIED SETTINGS. UNABLE TO RESOLVE WITH EXISTING TROUBLESHOOTING OR LABELED INSTRUCTIONS, ISSUE ESCALATED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE USING THE APPLICATION. NO PRODUCT RETURN IS REQUIRED FOR MMT-7350.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337456 CARELINK PRO ONLINE CONTINUOUS GLUCOSE MONITOR RETROSPECTIVE DATA ANALYSIS SOFTWARE PHV MEDTRONIC MINIMED MMT-7350

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown