BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK PERSONAL MMT-7333

    MDR report key: 19593187 · Received June 24, 2024

    Report

    Report Number
    2032227-2024-190905
    Event Type
    Malfunction
    Date Received
    June 24, 2024
    Date of Event
    June 7, 2024
    Report Date
    June 24, 2024
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P150001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5. HELPLINE SUPPORT TEAM REPORTED THAT THERE ARE DOTTED LINES PLOTTED IN SG GRAPH IN CARELINK DAILY AND WEEKLY REPORTS. INVESTIGATION/TESTING SUMMARY: AN ATTEMPT WAS MADE TO REPRODUCE THE ISSUE BY GENERATING DAILY REVIEW REPORT FOR THE GIVEN USER IN CARELINK SUPPORT APPLICATION AND OBSERVED THAT THIS IS WORKING AS PER SYSTEM DESIGN. AFTER CONDUCTING THOROUGH INVESTIGATION BY LOOKING IN TO THE SOFTWARE REQUIREMENT DOCUMENT WE PROVIDED THE BELOW FEEDBACK TO HELPLINE SUPPORT TEAM. -- **HCL (HYBRID CLOSED LOOP)/AHCL (ADVANCED HYBRID CLOSED LOOP) ALGORITHM USES REAL-TIME SG READING TO CALCULATE THE REQUIRED INSULIN DOSAGE. HOWEVER, IF A SENSOR IS DISCONNECTED FROM A PUMP AND LATER CONNECTED AGAIN, THE SGS WILL BE BACKFILLED TO THE PUMP. THE ALGORITHM WILL NOT BE ABLE TO USE BACKFIELD SGS SINCE THEY ARE NOT REAL-TIME. THE SOFTWARE SUCCESSFULLY ADHERED TO THE SPECIFIED REQUIREMENTS AND PERFORMED IN ACCORDANCE WITH THE EXPECTATIONS SPECIFIED IN THE SOFTWARE REQUIREMENT AND SPECIFICATION DOCUMENT LISTED BELOW UNDER ""SW REQUIREMENT DOC. (MOST LIKELY) ROOT CAUSE: WE CANNOT DERIVE A ROOT CAUSE FOR THIS ISSUE SINCE IT IS A CURRENT SYSTEM REQUIREMENT. ANALYSIS SUMMARY: WE ARE PROCEEDING TO CLOSE THIS TICKET AS THIS IS A SYSTEM REQUIREMENT WHICH IS IMPLEMENTED AS PART OF CARELINK RELEASE 14.12. 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) MMT-7333. TROUBLESHOOTING WAS PERFORMED AND ISSUE WAS NOT RESOLVED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. NO PRODUCT RETURN IS REQUIRED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2193789 CARELINK PERSONAL MMT-7333 SENSOR, GLUCOSE, INVASIVE MDS MEDTRONIC MINIMED MMT-7333

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Unknown