BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT MMT-105NNBLW1 NOVONORDISK BLUE OUS1

    MDR report key: 24185376 · Received January 26, 2026

    Report

    Report Number
    3012822846-2026-00153
    Event Type
    Malfunction
    Date Received
    January 26, 2026
    Date of Event
    January 14, 2026
    Report Date
    April 1, 2026
    Manufacturer
    COMPANION MEDICAL INC
    Product Code
    FMF
    UDI-DI
    000076300082391701
    PMA / PMN Number
    K201337
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SYSTEM IS NOT ACCEPTING 424 (CAP) AS COMPONENT CODE AND INVESTIGATION FINDINGS CODE. HENCE, MENTIONING IT HERE. TYPE OF INVESTIGATION FINDINGS INVESTIGATION CONCLUSIONS 10 424 2306 INPEN RECEIVED PHYSICALLY DAMAGED. ELECTRONIC HOUSING PHYSICALLY DAMAGE FROM DOSE KNOB. DOSE DETENT BOND WAS BROKEN. UNABLE TO PAIR INPEN DUE TO PHYSICAL DAMAGE. UNABLE TO PERFORM BASELINE AND WIRELESS FUNCTIONALITY AND DISPLACEMENT DOSE ACCURACY. UNABLE TO CONFIRM INPEN FRONT CAP INVESTIGATION DUE TO INPEN WAS RECEIVED WITH NO ORIGINAL FRONT CAP SHELL. IN CONCLUSION: INPEN RECEIVED WITH FLEX PCBA BROKEN OFF ALONG WITH INJECTION BUTTON. THEREFORE, THE CUSTOMER¿S CONCERN FOR DOSE LOG INACCURACY WAS NOT CONFIRMED. FRONT CAP SHELL WAS RECEIVED MISSING. 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

    SELECT PATIENT INFORMATION CANNOT BE PROVIDED DUE TO REGIONAL PRIVACY REGULATIONS. THE REPORTED DEVICE IS NOT MARKETED IN THE UNITED STATES, BUT IT IS A SAME/SIMILAR DEVICE TO ONE THAT IS MARKETED INSIDE THE UNITED STATES. 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 ALLEGED DOSE DIALED IN THE INPEN IS NOT REGISTERED IN THE INPEN APP. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT MMT-105NNBLW1. TROUBLESHOOTING WAS PERFORMED AND DOSE KNOB/DIAL MISALIGNMENT GREATER THAN 1.0 UNIT. NO HARM REQUIRING MEDICAL INTERVENTIONS WERE REPORTED. THE PRODUCT MMT-105NNBLW1 WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230191 KIT MMT-105NNBLW1 NOVONORDISK BLUE OUS1 SYRINGE, PISTON FMF COMPANION MEDICAL INC MMT-105NNBLW1 D0127 000076300082391701

    Patients

    Seq Age Sex Outcome Treatment
    1