BEUDAMED
    FDA Adverse Event Death Summary report: N

    INPEN MMT-105ELBLNA ELI LILY BLUE

    MDR report key: 24330986 · Received February 13, 2026

    Report

    Report Number
    3012822846-2026-00332
    Event Type
    Death
    Date Received
    February 13, 2026
    Date of Event
    January 21, 2026
    Report Date
    February 13, 2026
    Manufacturer
    COMPANION MEDICAL INC
    Product Code
    FMF
    UDI-DI
    000000763000827151
    PMA / PMN Number
    K201337
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER DIED ON (B)(6) 2026. THE CAUSE OF DEATH WAS DIABETIC KETOACIDOSIS (DKA). THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. THE EVENT INVOLVED PRODUCT(S) MMT-105ELBLNA. TROUBLESHOOTING WAS PARTIALLY PERFORMED. CUSTOMER DEATH REPORTED WITH CAUSE OF DEATH IS POTENTIALLY RELATED TO DIABETES. IT WAS UNKNOWN WHETHER MEDTRONIC PRODUCTS CAUSED OR CONTRIBUTED TO THE CUSTOMER¿S DEATH. NO PRODUCT RETURN IS REQUIRED FOR MMT-105ELBLNA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393502 INPEN MMT-105ELBLNA ELI LILY BLUE SYRINGE, PISTON FMF COMPANION MEDICAL INC MMT-105ELBLNA D0035 000000763000827151

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Death