BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INPEN MMT-105NNBLNA NOVO NORDISK BLUE

    MDR report key: 22736674 · Received August 7, 2025

    Report

    Report Number
    3012822846-2025-00766
    Event Type
    Malfunction
    Date Received
    August 7, 2025
    Date of Event
    June 20, 2025
    Report Date
    September 7, 2025
    Manufacturer
    COMPANION MEDICAL INC
    Product Code
    FMF
    UDI-DI
    000000763000827182
    PMA / PMN Number
    K201337
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 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: 5.40OZF-IN). NO MISSING INJECTION FOOT NOTED. UNABLE TO DETERMINE INPEN FRONT CAP INVESTIGATION DUE TO INPEN NOT RECEIVED WITH ORIGINAL FRONT CAP. IN CONCLUSION: NO MECHANICAL MALFUNCTIONS NOTED DURING TESTING THAT COULD AFFECT INSULIN DELIVERY. THEREFORE, THE CUSTOMER CONCERN OF LEADSCREW ANOMALY COULD NOT BE CONFIRMED. HOWEVER, INPEN RECEIVED WITHOUT ORIGINAL FRONT CAP. MISSING OR PHYSICALLY DAMAGED FRONT CAPS 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 CUSTOMER INPEN DAMAGED AND BLACK TIP SCREW THAT PUSHES THE INSULIN CAME OFF. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT MMT-105NNBLNA. TROUBLESHOOTING WAS PERFORMED. INSTRUCTED THE CUSTOMER TO REVERT TO BACKUP PLAN AS PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. MMT-105NNBLNA WAS REQUESTED AND CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED. THE CUSTOMER WILL DISCONTINUE THE USE OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505226 INPEN MMT-105NNBLNA NOVO NORDISK BLUE SYRINGE, PISTON FMF COMPANION MEDICAL INC MMT-105NNBLNA D0055 000000763000827182

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female