BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INPEN MMT-105ELGYNA ELI LILY GRAY

    MDR report key: 17717546 · Received September 11, 2023

    Report

    Report Number
    3012822846-2023-01568
    Event Type
    Malfunction
    Date Received
    September 11, 2023
    Date of Event
    August 21, 2023
    Report Date
    November 8, 2023
    Manufacturer
    COMPANION MEDICAL INC
    Product Code
    FMF
    UDI-DI
    000010862088000320
    PMA / PMN Number
    K201337
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 PAIRED TO THE COMMERCIAL APP. PERFORMED DUST/DEBRIS INVESTIGATION AND FOUND VISIBLE HORIZONTAL ABRASIONS AND DUST/DEBRIS ON THE OUTSIDE OF ELECTRONICS HOUSING. DEBRIS WAS LODGED BETWEEN THE DOSE KNOB AND ELECTRONICS HOUSING CAUSING THE LEADSCREW TO RETRACT. PERFORMED LEADSCREW RESET TORQUE TEST. INPEN PASSED AND IS WITHIN SPECIFICATION (CW: 2.70 OZF-IN AND CCW: 4.80 OZF-IN). UNABLE TO PERFORM BASELINE/WIRELESS FUNCTIONALITY AND DISPLACEMENT DOSE ACCURACY TEST. INPEN PASSED FRONT CAP INVESTIGATION. 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, LEADSCREW ANOMALY WAS CONFIRMED. UNABLE TO CONFIRM POSSIBLE UNDER DELIVERY DUE TO RETRACTING LEADSCREW. 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 NO INSULIN WAS COMING OUT. THE CUSTOMER CHANGED THE CARTRIDGE, AND THE INPEN STARTED WORKING BUT THEN AGAIN STOPPED AGAIN. TROUBLESHOOTING WAS PARTIALLY PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE THE USE OF THE DEVICE. THE PRODUCT WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1890914 INPEN MMT-105ELGYNA ELI LILY GRAY SYRINGE, PISTON FMF COMPANION MEDICAL INC MMT-105ELGYNA B1624 000010862088000320

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Male