BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INPEN MMT-105ELGYNA ELI LILY GRAY

    MDR report key: 17905115 · Received October 10, 2023

    Report

    Report Number
    3012822846-2023-01676
    Event Type
    Malfunction
    Date Received
    October 10, 2023
    Date of Event
    September 12, 2023
    Report Date
    November 28, 2023
    Manufacturer
    COMPANION MEDICAL INC
    Product Code
    FMF
    UDI-DI
    0000108620880003
    PMA / PMN Number
    K201337
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PER VISUAL INSPECTION: NO PHYSICAL DAMAGE TO CARTRIDGE HOLDER OR INPEN FRONT AND BACK SHELL WAS NOTED. CARTRIDGE HOLDER LOCKS PROPERLY IN PLACE. INPEN DID NOT PAIR WITH COMMERCIAL APP. HOWEVER, INPEN DID NOT TRANSMIT TO MANUFACTURING APP. PERFORMED ENCODER BOND INVESTIGATION AND FOUND THAT THE ENCODER PATTERN WHEEL TABS ROTATING AND TRAVELING OFF THE KEYED SLOTS OF DOSE NUT GUIDES. ENCODER PATTERN WHEEL SHOULD NEVER ROTATE. THIS CAUSES AN UNEXPECTED TRAVEL OF THE ENCODER PATTERN WHEEL CREATING RESISTANCE TO DIAL AND DISPENSING. ALSO, PLASTIC SHAVINGS CONTAMINATION BUILDS UP FOUND CAUSED BY ENCODER WHEEL TABS RUBBING AT THE WALLS OF THE DOSE NUT. ABRASIONS DOWN THE LENGTH OF THE DOSE NUT. PERFORMED LEADSCREW RESET TORQUE. INPEN WITHIN SPECIFICATION (CW: 0.25 OZF-IN AND CCW: 2.85 OZF-IN). UNABLE TO PERFORM BASELINE/WIRELESS FUNCTIONALITY AND DISPLACEMENT DOSE ACCURACY TEST. INPEN PASSED FRONT CAP INVESTIGATION. IN CONCLUSION: IT WAS DETERMINED FROM DESTRUCTIVE ANALYSIS THAT THE DIFFICULT TO DIAL/DOSE WAS CAUSED BY A PATTERN WHEEL MISALIGNMENT DUE TO AN ENCODER BASE BOND FAILURE. THIS CAN AFFECT INSULIN DELIVERY. THEREFORE, THE CUSTOMER CONCERN OF DOSE DIAL BEING DIFFICULT TO DIAL/DOSE WAS CONFIRMED. LEADSCREW ANOMALY WAS NOT CONFIRMED. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Additional Manufacturer Narrative · 0

    PER VISUAL INSPECTION: NO PHYSICAL DAMAGE TO CARTRIDGE HOLDER OR INPEN FRONT AND BACK SHELL WAS NOTED. CARTRIDGE HOLDER LOCKS PROPERLY IN PLACE. INPEN DID NOT PAIR WITH COMMERCIAL APP. HOWEVER, INPEN DID NOT TRANSMIT TO MANUFACTURING APP. PERFORMED ENCODER BOND INVESTIGATION AND FOUND THAT THE ENCODER PATTERN WHEEL TABS ROTATING AND TRAVELING OFF THE KEYED SLOTS OF DOSE NUT GUIDES. ENCODER PATTERN WHEEL SHOULD NEVER ROTATE. THIS CAUSES AN UNEXPECTED TRAVEL OF THE ENCODER PATTERN WHEEL CREATING RESISTANCE TO DIAL AND DISPENSING. ALSO, PLASTIC SHAVINGS CONTAMINATION BUILDS UP FOUND CAUSED BY ENCODER WHEEL TABS RUBBING AT THE WALLS OF THE DOSE NUT. ABRASIONS DOWN THE LENGTH OF THE DOSE NUT. PERFORMED LEADSCREW RESET TORQUE. INPEN WITHIN SPECIFICATION (CW: 0.25 OZF-IN AND CCW: 2.85 OZF-IN). UNABLE TO PERFORM BASELINE/WIRELESS FUNCTIONALITY AND DISPLACEMENT DOSE ACCURACY TEST. INPEN PASSED FRONT CAP INVESTIGATION. IN CONCLUSION: IT WAS DETERMINED FROM DESTRUCTIVE ANALYSIS THAT THE DIFFICULT TO DIAL/DOSE WAS CAUSED BY A PATTERN WHEEL MISALIGNMENT DUE TO AN ENCODER BASE BOND FAILURE. THIS CAN AFFECT INSULIN DELIVERY. THEREFORE, THE CUSTOMER CONCERN OF DOSE DIAL BEING DIFFICULT TO DIAL/DOSE WAS CONFIRMED. LEADSCREW ANOMALY WAS NOT CONFIRMED. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Description of Event or Problem · 0

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INPEN BATTERY LIFE ISSUE AND SCREW MOVEMENT ISSUE. TROUBLESHOOTING WAS PERFORMED AND IT WAS FOUND THAT THE DOSE KNOB/DIAL WAS DIFFICULT TO TURN. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE USING THE INPEN. THE INPEN WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335764 INPEN MMT-105ELGYNA ELI LILY GRAY SYRINGE, PISTON FMF COMPANION MEDICAL INC MMT-105ELGYNA B1569 0000108620880003

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Female