BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR MMT-5100CLX CLINICAL 5PK US

    MDR report key: 19481324 · Received June 6, 2024

    Report

    Report Number
    2032227-2024-182398
    Event Type
    Malfunction
    Date Received
    June 6, 2024
    Date of Event
    March 21, 2024
    Report Date
    August 2, 2024
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    PQF
    UDI-DI
    0000207630005650
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    RECEIVED 1 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/COSMETIC DAMAGE AND NONE WERE FOUND. THEN, PERFORMED A VISUAL INSPECTION ON THE SERTER PRODUCT FOR PHYSICAL/COSMETIC DAMAGE (DENTS OR CRACKS ON THE SERTER SHELL/TYREK), NONE WERE FOUND. THE UNIT WAS ABLE TO DOWNLOAD TRACES THROUGH (THE BLUE DONGLE DOWNLOAD STATION) (UTILIZING SYNERGY PROD DOWNLOAD TOOL 1.1A). LOST SENSOR ALARM WAS FOUND (RFSAKE FAILED, HOWEVER UNIT RECONNECTED AND RECEIVED A SUCCESSFUL SAKE SEQUENCE AS DESIGNED.) NO COMMUNICATION ANOMALIES FOUND. UNIT WAS ABLE TO DOWNLOAD TRACE AND TERMINATION RESULT. FIRST TERM REASON: SENSOR DEHYDRATION. FIRST TERM REASON DESCRIPTOR: THE SENSOR WAS TERMINATED BECAUSE IT WAS REMOVED FROM THE BODY PRIOR TO THE DEVICE'S END OF LIFE. THE DEHYDRATION CAN BE CAUSED BY MULTIPLE FACTORS. IT IS UNKNOWN THAT THE SENSOR CONTRIBUTED TO THE EVENT. IN CONCLUSION: THE CUSTOMER COMPLAINT OF NOT COMMUNICATING IS NOT CONFIRMED. THE UNIT IS WORKING AS EXPECTED. CSC UPDATED-NOTES WERE ADDED IN SVN 317457314 THAT SITE PHYSICALLY RETURNED SN B246-023-789 INSTEAD OF SN B218-009-619 (ORIGINAL REPORTED TO TS ). FA TEAM TO PROCEED AND FACILITATE THE ANALYSIS ON SN B246-023-789 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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. 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 NO COMMUNICATION BETWEEN THE TRANSMITTER AND THE PUMP. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-5100CLX. TROUBLESHOOTING WAS PERFORMED FOR THE EVENT. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. MMT-5100CLX WAS REQUESTED AND CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1259964 SENSOR MMT-5100CLX CLINICAL 5PK US SENSOR, GLUCOSE, INVASIVE , NON-ADJUNCTIVE PQF MEDTRONIC MINIMED MMT-5100CLX HG7994T 0000207630005650

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown