BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR MMT-7020A ENLITE3 5PK US

    MDR report key: 21065075 · Received January 3, 2025

    Report

    Report Number
    2032227-2025-101452
    Event Type
    Malfunction
    Date Received
    January 3, 2025
    Date of Event
    December 14, 2024
    Report Date
    March 6, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    002076300045566201
    PMA / PMN Number
    P160007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOWING OUR RECEIPT OF THE ONE RETURNED USED SENSOR AND PERFORMED VISUAL INSPECTION AND CHECKED FOR PHYSICAL DAMAGE AND NONE WAS FOUND (NO MICROSCOPE). THEN PERFORMED CONTINUITY RESISTANCE TEST TO VERIFY (OPEN TRACE), ELECTRICAL INTERRUPTION IN THE SENSOR CIRCUIT AND SENSOR PASSED PER SPECIFICATION. PERFORMED BICARBONATE BUFFER TEST AND SENSOR PASSED PER SPECIFICATIONS WITH ACCURATE READINGS. SEE ATTACHED FILE FOR RESULTS. IN SUMMARY, SENSOR PASSED PER SPECIFICATIONS SUBMERGE SENSOR UNDER DIFFERENT LEVELS OF GLUCOSE AND SENSOR PASSED WITH ACCURATE READINGS. UNABLE TO CONFIRM CUSTOMER COMPLAINT OF SG V BG. 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

    THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5. 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. 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 DIFFERENCES IN SENSOR GLUCOSE VS. BLOOD GLUCOSE. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-7020A AND MMT-7811NA. THE TROUBLESHOOTING WAS PERFORMED AND THE CUSTOMER WAS REPORTING A DISCREPANCY BETWEEN SUGAR GLUCOSE AND BLOOD GLUCOSE THAT WAS NOT WITHIN RANGE. THE EXPLAINED SENSOR MAY HAVE NO LONGER BEEN RESPONDING TO GLUCOSE CHANGES. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. MMT-7020A WAS REQUESTED AND THE CUSTOMER RESPONSE WAS THAT THE DEVICE WILL BE RETURNED. IT WAS UNKNOWN WHETHER THE CUSTOMER WOULD CONTINUE USING THE DEVICE. NO PRODUCT RETURN IS REQUIRED FOR MMT-7811NA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571665 SENSOR MMT-7020A ENLITE3 5PK US AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-7020A HG7XSN8 002076300045566201

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Male