BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INPEN MMT-105NNPKNA NOVO NORDISK PINK

    MDR report key: 23275176 · Received October 12, 2025

    Report

    Report Number
    3012822846-2025-01313
    Event Type
    Malfunction
    Date Received
    October 12, 2025
    Date of Event
    September 21, 2025
    Report Date
    October 27, 2025
    Manufacturer
    COMPANION MEDICAL INC
    Product Code
    FMF
    UDI-DI
    000000763000827205
    PMA / PMN Number
    K201337
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, 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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. 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.

    Additional Manufacturer Narrative · 0

    SYSTEM IS NOT ACCEPTING 424 (CAP) AS COMPONENT CODE AND INVESTIGATION FINDINGS CODE. HENCE, MENTIONING IT HERE. TYPE OF INVESTIGATION INVESTIGATION FINDINGS INVESTIGATION CONCLUSIONS 10 424 2306 UNIT PAIRED SUCCESSFULLY TO COMMERCIAL APP. INPEN RECEIVED WITH LEADSCREW FULLY REWOUND. INPEN PASSED FRONT CAP INVESTIGATION. UNABLE TO PERFORM BASELINE AND WIRELESS FUNCTIONALITY AND DISPLACEMENT DOSE ACCURACY DUE TO MISSING INJECTION FOOT. UNABLE TO PERFORM FRONT CAP INVESTIGATION DUE TO MISSING FRONT CAP. IN CONCLUSION NO INSULIN IS DISPENSED WHEN THE INJECTION/DOSE BUTTON IS PUSHED, MISSING INJECTION FOOT WAS NOTED. NOT ABLE TO CONFIRM CUSTOMER'S COMPLAINT FOR DOSE DIAL IS DIFFICULT TO TURN/DIAL DUE TO MISSING INJECTION FOOT. MISSING FRONT CAP AND CARTRIDGE HOLDER CAN AFFECT INSULIN DELIVERY. 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 INPEN BECAME DAMAGED WHILE CHANGING THE CARTRIDGE. THE DOSE KNOB/DIAL BECAME STIFF, JAMMED, OR STUCK, AND THE DOSE BUTTON WAS DETACHED FROM THE INPEN. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-105NNPKNA. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WOULD BE REPLACED AND ADVISED TO REVERT TO A BACKUP PLAN PER THE HEALTHCARE PROFESSIONAL'S INSTRUCTIONS. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE USE OF THE INSULIN PEN. MMT-105NNPKNA WAS REQUESTED, AND THE CUSTOMER RESPONDED THAT THE DEVICE WOULD BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1982145 INPEN MMT-105NNPKNA NOVO NORDISK PINK SYRINGE, PISTON FMF COMPANION MEDICAL INC MMT-105NNPKNA D0098 000000763000827205

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female