BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INPEN MMT-105ELGYNA ELI LILY GRAY

    MDR report key: 17114879 · Received June 13, 2023

    Report

    Report Number
    3012822846-2023-01066
    Event Type
    Malfunction
    Date Received
    June 13, 2023
    Date of Event
    February 18, 2023
    Report Date
    June 12, 2023
    Manufacturer
    COMPANION MEDICAL INC
    Product Code
    FMF
    UDI-DI
    0000108620880003
    PMA / PMN Number
    K201337
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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. INPEN DID NOT PAIR TO THE COMMERCIAL APP. HOWEVER, INPEN TRANSMITTED TO MANUFACTURING APP. INPEN RECEIVED WITH LEADSCREW 1/4 OF TRAVEL. PERFORMED DUST/DEBRIS INVESTIGATION AND FOUND VISIBLE HORIZONTAL ABRASIONS ON THE OUTSIDE OF ELECTRONICS HOUSING WERE NOTED. THIS INDICATED DEBRIS WAS LODGED BETWEEN THE KNOB AND ELECTRONICS HOUSING CAUSING THE LEADSCREW ANOMALY. 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 LEADSCREW NOT MOVING AND UNABLE TO DELIVER INSULIN WAS CONFIRMED. NO COSMETIC DAMAGES WERE NOTED. 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 PLUNGER WAS NOT ABLE TO MOVE. TROUBLESHOOTING WAS PERFORMED AND THE ISSUE WAS NOT RESOLVED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE TO USE THE INPEN AND THE DEVICE WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252336 INPEN MMT-105ELGYNA ELI LILY GRAY SYRINGE, PISTON FMF COMPANION MEDICAL INC MMT-105ELGYNA B0488 0000108620880003

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female