BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INPEN MMT-105ELGYNA ELI LILY GRAY

    MDR report key: 18202959 · Received November 23, 2023

    Report

    Report Number
    3012822846-2023-01927
    Event Type
    Injury
    Date Received
    November 23, 2023
    Date of Event
    October 31, 2023
    Report Date
    February 27, 2024
    Manufacturer
    COMPANION MEDICAL INC
    Product Code
    FMF
    UDI-DI
    000010862088000320
    PMA / PMN Number
    K201337
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 SUCCESSFULLY PAIRED TO THE COMMERCIAL APP. INPEN SUCCESSFULLY TRANSMITTED TO MANUFACTURING APP. INPEN PASSED BASELINE AND WIRELESS FUNCTIONALITY. APP LOGBOOK DISPLAYED: 15U, 15U, 15U, 15U, 15U, 15U, 15U, 15U, 15U, 15U. INPEN PASSED PERFORMED LEAK TEST AND NO PRIMING / DELIVERY ANOMALY WAS NOTED. NO LEAKAGE WAS NOTED AROUND CARTRIDGE HOLDER AREA. PERFORMED DUST/DEBRIS INVESTIGATION AND FOUND NO EVIDENCE OF ABRASIONS OR SIGNS OF STICKY FLUID AROUND THE ELECTRONICS HOUSING. INPEN WAS CUT OPEN TO PERFORM VISUAL INSPECTION UNDER MICROSCOPE AND ENCODER BOND INVESTIGATION. ENCODER BOND AND THE PATTERN WHEEL ASSEMBLY WERE FOUND INTACT. NO PHYSICAL OR MOISTURE DAMAGE WERE NOTED. PERFORMED LEADSCREW RESET TORQUE TEST. INPEN PASSED AND IS WITHIN SPECIFICATION (CCW: 4.90OZF-IN). INPEN PASSED FRONT CAP INVESTIGATION. IN CONCLUSION: NO LEAKS WERE CONFIRMED DURING TESTING. THEREFORE, LEAKAGE AT THE CARTRIDGE HOLDER AREA COULD NOT BE CONFIRMED. MOISTURE DAMAGE WAS NOT CONFIRMED. UNABLE TO CONFIRM HIGH BG. 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

    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, 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 CUSTOMER REPORTED THE INSULIN DOES NOT EXIST WHEN THE DOSE BUTTON WAS PUSHED. TROUBLESHOOTING WAS PERFORMED AND FOUND THAT THE INPEN WAS EXPOSED TO COLD TEMPERATURES. THE CUSTOMER DOES NOT REPORT THE DOSE KNOB/DIAL WAS DIFFICULT TO TURN AND THAT RETRACTING THE SCREW WAS DIFFICULT. THE CUSTOMER STATED THAT THE INJECTION FOOT TOUCHED THE PLUNGER INSIDE THE CARTRIDGE. THE CUSTOMER DID NOT TOUCH/TWIST THE INJECTION/DOSE BUTTON AND THE SCREW WAS PULLING BACK INTO THE INPEN WHILE DIALING. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE USING THE INPEN AND THE INPEN WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1219806 INPEN MMT-105ELGYNA ELI LILY GRAY SYRINGE, PISTON FMF COMPANION MEDICAL INC MMT-105ELGYNA B1872 000010862088000320

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention