BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INPEN MMT-105NNPKNA NOVO NORDISK PINK

    MDR report key: 17206388 · Received June 27, 2023

    Report

    Report Number
    3012822846-2023-01167
    Event Type
    Malfunction
    Date Received
    June 27, 2023
    Date of Event
    May 12, 2023
    Report Date
    June 26, 2023
    Manufacturer
    COMPANION MEDICAL INC
    Product Code
    FMF
    UDI-DI
    000010862088000368
    PMA / PMN Number
    K201337
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER REPORTS: DOSES ARE NOT TRANSMITTING TO INPEN APP. PER VISUAL INSPECTION: NO PHYSICAL DAMAGE NOTED TO CARTRIDGE HOLDER AND INPEN FRONT AND BACK SHELL. INPEN PAIRED TO THE COMMERCIAL APP. INPEN RECEIVED WITH LEADSCREW 1/4 OF TRAVEL. PERFORMED BAYONET BOND INVESTIGATION AND FOUND LEADSCREW AND CARTRIDGE STOP ROTATING TOGETHER WHEN DISPENSING DUE TO BROKEN BAYONET BOND. UNABLE TO PERFORM DISPLACEMENT DOSE ACCURACY TEST. INPEN FAILED BASELINE AND WIRELESS FUNCTIONALITY. APP LOGBOOK DISPLAYED: 14.5U, 14U, 14.5U, 15U, 14U. DOSES STOPPED TRANSMITTING TO LOGBOOK DASHBOARD. PERFORMED BATTERY INVESTIGATION AND BATTERY MEASURED 3V. BATTERY AND ELECTRONICS WERE FOUND CORRODED. INPEN PASSED FRONT CAP INVESTIGATION. IN CONCLUSION: BROKEN BAYONET BOND CAN AFFECT INSULIN DELIVERY. IT WAS DETERMINED THE CAUSE OF INPEN NOT TRANSMITTING DOSES WAS CAUSED BY FLUID INTRUSION TO THE BATTERY. THEREFORE, THE CUSTOMER CONCERN OF INPEN NOT TRANSMITTING DOSES WAS CONFIRMED. LEADSCREW ANOMALY WAS ALSO 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 CUSTOMER REPORTED A CONNECTION ISSUE BETWEEN THE INPEN AND THE MOBILE. TROUBLESHOOTING WAS PERFORMED AND THE INPEN WAS PAIRED SUCCESSFULLY, HOWEVER THE LOG BOOK DOES NOT SHOW 2 UNITS. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE TO USE THE INPEN AND THE PRODUCT WAS WAS BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1452486 INPEN MMT-105NNPKNA NOVO NORDISK PINK SYRINGE, PISTON FMF COMPANION MEDICAL INC MMT-105NNPKNA B1578 000010862088000368

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female