BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INPEN MMT-105NNPKNA NOVO NORDISK PINK

    MDR report key: 24206571 · Received January 28, 2026

    Report

    Report Number
    3012822846-2026-00179
    Event Type
    Malfunction
    Date Received
    January 28, 2026
    Date of Event
    January 7, 2026
    Report Date
    March 4, 2026
    Manufacturer
    COMPANION MEDICAL INC
    Product Code
    FMF
    UDI-DI
    000000763000827205
    PMA / PMN Number
    K201337
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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. 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.

    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 UNIT PAIRED SUCCESSFULLY TO COMMERCIAL APP. INPEN RECEIVED WITH LEADSCREW 1/4 OF THE TRAVEL. INPEN PASSED BASELINE AND WIRELESS FUNCTIONALITY. APP LOGBOOK DISPLAYED: 15U, 15U, 15U, 15U, 15U, 15U, 15U, 15U, 15U, 15U. INPEN PASSED DISPLACEMENT DOSE ACCURACY. PERFORMED LEADSCREW RESET TORQUE TEST. INPEN PASSED AND IS WITHIN SPECIFICATION (CCW: 5.15OZF-IN). IUNABLE TO CONFIRM FRONT CAP INVESTIGATION DUE TO INPEN WAS RECEIVED WITH NO ORIGINAL FRONT CAP SHELL. IN CONCLUSION: NO MECHANICAL MALFUNCTIONS NOTED DURING TESTING THAT COULD AFFECT INSULIN DELIVERY. THEREFORE, THE CUSTOMER CONCERN OF LEADSCREW ANOMALY COULD NOT BE CONFIRMED. UNABLE TO OBTAINED INPEN BOND DATES OR BATTERY PERCENTAGES DUE TO DOWNLOAD (LOOKER STUDIO) ERROR. 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 NEED A REPLACEMENT INPEN AS IT IS ONLY INJECTING AIR AT A RESULT. THE CUSTOMER REPORTED INPEN SCREW MOVEMENT ISSUE. THE CUSTOMER REPORTED A BLOOD GLUCOSE VALUE OF 368 MG/DL. THE CUSTOMER EXPERIENCED HYPERGLYCEMIA, AND WAS TREATED WITH A MANUAL INJECTION/INSULIN PEN. THE EVENT INVOLVED PRODUCT(S) MMT-105NNPKNA. TROUBLESHOOTING WAS NOT PERFORMED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE CUSTOMER WAS INSTRUCTED TO DISCONTINUE DEVICE USE AND REVERT TO THE BACKUP PLAN WITH THE HEALTH CARE PROFESSIONAL'S INSTRUCTIONS. MMT-105NNPKNA WAS REQUESTED, AND THE CUSTOMER'S RESPONSE WAS THAT THE DEVICE WOULD BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51259 INPEN MMT-105NNPKNA NOVO NORDISK PINK SYRINGE, PISTON FMF COMPANION MEDICAL INC MMT-105NNPKNA D0086 000000763000827205

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male