BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR MMT-5100JD1 SIMPLERA 1PK OUS1

    MDR report key: 19077487 · Received April 10, 2024

    Report

    Report Number
    2032227-2024-152183
    Event Type
    Malfunction
    Date Received
    April 10, 2024
    Date of Event
    March 23, 2024
    Report Date
    May 22, 2024
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    PQF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    RECEIVED 1 OPENED/USED SIMPLERA SENSOR/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: 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 SG V BG ANOMALY IS CONFIRMED. HOWEVER, IT IS UNKNOW IF THE SENSOR CONTRIBUTED TO THE ANOMALY. 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 AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. 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 SENSOR GLUCOSE VS. BLOOD GLUCOSE. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-5100JD1. CUSTOMER IS REPORTING A DISCREPANCY BETWEEN SG AND BG WHICH IS NOT WITHIN RANGE. TROUBLESHOOTING WAS PERFORMED. EXPLAINED SENSOR MAY HAVE NO LONGER BEEN RESPONDING TO GLUCOSE CHANGES. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. MMT-5100JD1 WAS REQUESTED AND CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412433 SENSOR MMT-5100JD1 SIMPLERA 1PK OUS1 SENSOR, GLUCOSE, INVASIVE, NON-ADJUNCTIVE PQF MEDTRONIC MINIMED MMT-5100JD1

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Unknown