BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK PRO ONLINE

    MDR report key: 25107665 · Received May 6, 2026

    Report

    Report Number
    2032227-2026-170621
    Event Type
    Malfunction
    Date Received
    May 6, 2026
    Date of Event
    April 28, 2026
    Report Date
    May 11, 2026
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    PHV
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    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 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

    AN ATTEMPT TO REPRODUCE THE ISSUE WAS NOT PERFORMED AS TESTING OR REPRODUCTION WOULD NOT YIELD RESULTS THAT WOULD CONFIRM OR DENY THE ISSUE. INSTEAD THIS ISSUE WOULD BE INVESTIGATED THROUGH DATABASE APPLICATION LOGS. THIS ISSUE IS CONFIRMED. THE SOFTWARE SUCCESSFULLY ADHERED TO THE SPECIFIED REQUIREMENTS AND PERFORMED IN ACCORDANCE WITH THE EXPECTATIONS SPECIFIED IN THE SW REQUIREMENT DOC FIELD. AFTER A THOROUGH INVESTIGATION THE SOFTWARE SUPPORT TEAM CONFIRMED THE ISSUE WAS MOST LIKELY CAUSED BY A TEMPORARY SERVERSIDE OR CDN ENCODING PROBLEM THAT AFFECTED HOW THE WEB PAGE TEXT WAS DELIVERED. ONCE THE SERVER RESPONSE NORMALIZED, THE PAGE DISPLAYED CORRECTLY WITHOUT ANY USERSIDE CHANGES. THE MOST LIKELY ROOT CAUSE IS A TRANSIENT SERVERSIDE ENCODING OR CDN ISSUE. TO ASSIST WITH THE RESOLUTION OF THE ISSUE, WE PROVIDED THE HELPLINE TEAM WITH THE FOLLOWING WORKAROUND TO ENSURE THAT IT IS ADDRESSED EFFECTIVELY: PLEASE PROVIDE THE THE BROWSER NAME THAT THE CLINIC IS USING. TRY OPENING THE PAGE IN A DIFFERENT BROWSER OR AN INCOGNITO/PRIVATE WINDOW. WAIT A BIT AND TRY AGAIN LATER (THIS USUALLY RESOLVES THE ISSUE). IF POSSIBLE, SWITCH TO A DIFFERENT NETWORK (FOR EXAMPLE, WIFI TO MOBILE HOTSPOT). RESTART THE BROWSER AND RELOAD THE PAGE. THE HELPLINE HAS CONFIRMED THE RECOMMENDED STEPS HAVE SUCCESSFULLY RESOLVED THE ISSUE. 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 CARELINK WAS NOT DISPLAYED AS EXPECTED. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-7350. TROUBLESHOOTING WAS NOT PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. PRODUCT RETURN IS NOT APPLICABLE FOR NON PHYSICAL DEVICE MMT-7350.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570546 CARELINK PRO ONLINE CONTINUOUS GLUCOSE MONITOR RETROSPECTIVE DATA ANALYSIS SOFTWARE PHV MEDTRONIC MINIMED MMT-7350

    Patients

    Seq Age Sex Outcome Treatment
    1