BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INPEN MMT-105ELBLNA ELI LILY BLUE

    MDR report key: 23093443 · Received September 19, 2025

    Report

    Report Number
    3012822846-2025-01041
    Event Type
    Malfunction
    Date Received
    September 19, 2025
    Date of Event
    August 25, 2025
    Report Date
    November 18, 2025
    Manufacturer
    COMPANION MEDICAL INC
    Product Code
    FMF
    UDI-DI
    000000763000827151
    PMA / PMN Number
    K201337
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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 INVESTIGATION FINDINGS INVESTIGATION CONCLUSIONS 10 424 2306 INPEN DID PAIR TO THE COMMERCIAL APP. INPEN RECEIVED WITH LEADSCREW 3/4 OF TRAVEL. PERFORMED DUST/DEBRIS INVESTIGATION AND FOUND VISIBLE HORIZONTAL ABRASIONS AND STICKY FLUID ON THE OUTSIDE OF ELECTRONICS HOUSING WERE NOTED. THIS INDICATED DEBRIS WAS LODGED BETWEEN THE DOSE KNOB AND ELECTRONICS HOUSING CAUSING THE LEADSCREW ANOMALY. UNABLE TO PERFORM BASELINE/WIRELESS FUNCTIONALITY AND DISPLACEMENT DOSE ACCURACY TEST. UNABLE TO PERFORM FRONT CAP INVESTIGATION DUE TO INPEN NOT RECEIVED WITH ORIGINAL FRONT CAP. IN CONCLUSION: DECONSTRUCTIVE ANALYSIS DEMONSTRATED VISIBLE HORIZONTAL ABRASIONS ON THE ELECTRONICS HOUSING WERE NOTED. THIS INDICATED DEBRIS WAS LODGED BETWEEN THE KNOB AND ELECTRONICS HOUSING CAUSING THE LEADSCREW TO RETRACT. THIS CAN AFFECT INSULIN DELIVERY. THEREFORE, THE CUSTOMER CONCERN OF SCREW RETRACTING WHEN DIALING WAS CONFIRMED. MISSING 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.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER'S INPEN WAS NOT DOSING CORRECTLY, WITH THE SCREW TURNING THE WRONG WAY AND FAILING TO DISPENSE INSULIN WHEN THE INJECTION OR DOSE BUTTON WAS PUSHED. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT MMT-105ELBLNA. TROUBLESHOOTING WAS PERFORMED, INCLUDING ADVISING THE CUSTOMER TO TRY A NEW NEEDLE, PRIME THE INPEN TO CONFIRM INSULIN EXITS, AND OBSERVE THE SCREW MOVEMENT BY DIALING A 5-UNIT DOSE WITHOUT TOUCHING THE INJECTION OR DOSE BUTTON. THE CUSTOMER WAS INSTRUCTED TO DISCONTINUE USE OF THE INPEN, REVERT TO A BACKUP PLAN AS PER THE HEALTHCARE PROVIDER'S INSTRUCTIONS. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INPEN. MMT-105ELBLNA WAS REQUESTED, AND THE CUSTOMER'S RESPONSE WAS THAT THE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300977 INPEN MMT-105ELBLNA ELI LILY BLUE SYRINGE, PISTON FMF COMPANION MEDICAL INC MMT-105ELBLNA D0091 000000763000827151

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female