BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR MMT-5100CLX CLINICAL 5PK US

    MDR report key: 21908014 · Received April 25, 2025

    Report

    Report Number
    2032227-2025-162243
    Event Type
    Malfunction
    Date Received
    April 25, 2025
    Date of Event
    March 22, 2025
    Report Date
    June 11, 2025
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    PQF
    UDI-DI
    000020763000565064
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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

    SYSTEM IS NOT ACCEPTING THE CODE 2890 (FAILURE TO CALIBRATE) AS INVESTIGATION FINDINGS CODE. HENCE, MENTIONING IT HERE: TYPE OF INVESTIGATION; INVESTIGATION FINDINGS; INVESTIGATION - CONCLUSIONS 10, 2890, 133. FOLLOWING OUR RECEIPT OF ONE OPENED/USED SIMPLERA SENSOR, ONE SIMPLERA SERTER AND PERFORMED A VISUAL INSPECTION OF THE SENSOR FLEX ANY PHYSICAL DAMAGE AND NONE WERE FOUND. CHECKED THE TRANSMITTER CASING FOR ANY PHYSICAL DAMAGE AND NONE WERE FOUND. THE UNIT WAS ABLE TO DOWNLOAD TRACES THROUGH (THE BLUE DONGLE DOWNLOAD STATION) (UTILIZING SYNERGY PROD DOWNLOAD TOOL 1.1A). UNIT WAS ABLE TO DOWNLOAD TRACE AND TERMINATION RESULT. FIRST TERM REASON: MAXCALIBRATIONERRORSEXCEEDED FIRST TERM REASON DESCRIPTOR: DEVICE TERMINATED DUE TO AN INABILITY TO RECONCILE CONSECUTIVE BG (CALIBRATION) VALUES PROVIDED BY THE USER WITH THE STATE OF THE SYSTEM. DISAGREEMENT BETWEEN THE SYSTEM AND USER INPUT VALUES CAN OCCUR DUE TO USER ERROR IN MEASURING IN MEASURING BG OR INACCURATE SENSOR GLUCOSE PREDICTION. IT IS UNKNOWN THAT THE SENSOR CONTRIBUTED TO THE EVENT. IN CONCLUSION: THE CUSTOMER COMPLAINT OF UNEXPECTED SENSOR ALARMS WAS CONFIRMED. IT IS UNKNOWN THAT THE SENSOR CONTRIBUTED TO THE EVENT. 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 CHANGE SENSOR ALERT AND CALIBRATION NOT ACCEPTED ALERT. THE CUSTOMER WAS ALSO EXPERIENCED DIFFERENCES BETWEEN SENSOR GLUCOSE AND BLOOD GLUCOSE LEVELS AND THE INSULIN DELIVERY WAS NOT SUSPENDED. THE CUSTOMER BLOOD GLUCOSE WAS 315 MG/DL AND SENSOR GLUCOSE VALUE WAS 52 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-5100CLX. TROUBLESHOOTING WAS NOT PERFORMED, THE DIFFERENCE BETWEEN SENSOR GLUCOSE AND BLOOD GLUCOSE VALUES WAS BEYOND 30% LIMIT. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. NO PRODUCT RETURN IS REQUIRED FOR MMT-5100CLX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1164668 SENSOR MMT-5100CLX CLINICAL 5PK US SENSOR, GLUCOSE, INVASIVE , NON-ADJUNCTIVE PQF MEDTRONIC MINIMED MMT-5100CLX HG82EB8 000020763000565064

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female