BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INPEN MMT-105NNPKNA NOVO NORDISK PINK

    MDR report key: 24361458 · Received February 17, 2026

    Report

    Report Number
    3012822846-2026-00348
    Event Type
    Malfunction
    Date Received
    February 17, 2026
    Date of Event
    January 27, 2026
    Report Date
    February 16, 2026
    Manufacturer
    COMPANION MEDICAL INC
    Product Code
    FMF
    UDI-DI
    000010862088000368
    PMA / PMN Number
    K201337
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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

    ON (B)(6) 2026 10:02:30 D00360632_VER_T: INPEN DOSE(S) ARE NOT TRANSMITTED TO INPEN APP "UNABLE TO COMPLETE TROUBLESHOOTING OR PROVIDE INSTRUCTIONS, INSUFFICIENT INFORMATION TO ESCALATE." (B)(6) 2026 10:02:30 D00360632_VER_T: GENERAL DOCUMENTATION THE CUSTOMER CALLED FOR AN ISSUE NOT COVERED BY EXISTING TROUBLESHOOTING GUIDES. REFER TO THE EVENT DESCRIPTION FOR MORE DETAILS. (B)(6) /2026 10:02:30 D00360632_VER_T: DOSE LOG INACCURACY UNABLE TO COMPLETE TROUBLESHOOTING OR PROVIDE INSTRUCTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426289 INPEN MMT-105NNPKNA NOVO NORDISK PINK SYRINGE, PISTON FMF COMPANION MEDICAL INC MMT-105NNPKNA B1839 000010862088000368

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Unknown