BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INPEN MMT-105NNBLNA NOVO NORDISK BLUE

    MDR report key: 18595353 · Received January 29, 2024

    Report

    Report Number
    3012822846-2023-01622
    Event Type
    Malfunction
    Date Received
    January 29, 2024
    Date of Event
    September 3, 2023
    Report Date
    December 23, 2023
    Manufacturer
    COMPANION MEDICAL INC
    Product Code
    FMF
    UDI-DI
    000010862088000344
    PMA / PMN Number
    K201337
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PER VISUAL INSPECTION: FRONT SHELL DOES NOT STAY ATTACHED. NO PHYSICAL DAMAGE TO CARTRIDGE HOLDER OR INPEN BACK SHELL WAS NOTED. CARTRIDGE HOLDER LOCKS PROPERLY IN PLACE. THE INPEN PAIRED TO THE COMMERCIAL APP. INPEN PASSED BASELINE AND WIRELESS FUNCTIONALITY. APP LOGBOOK DISPLAYED: 15U, 15U, 15U, 15U, 15U, 15U, 15U, 15U, 15U, 15U. PERFORMED LEADSCREW RESET TORQUE TEST. INPEN WITHIN SPECIFICATION (CW: 0.35 OZF-IN AND CCW: 4.60 OZF-IN). INPEN FAILED DIALING ALIGNMENT. THE ZERO TICK MARK DID NOT CLEARLY APPEAR IN THE DOSE KNOB ZERO ALIGNMENT GAGE WINDOW WHEN DIALING 16U. INPEN FAILED FRONT CAP INVESTIGATION. INPEN FRONT SHELL DOES NOT FIT SECURELY ONTO CARTRIDGE HOLDER DUE TO SNAP ARM BEING CRACKED / BROKEN. PENDING FURTHER INVESTIGATION PERFORMED IN SAN DIEGO LOCATION. IN CONCLUSION: PER SAN DIEGO ANALYSIS: INPEN PASSED BASE LINE FUNCTIONALITY TEST AND DISPLACEMENT DOSE ACCURACY. INPEN PASSED LEADSCREW RESET TORQUE TEST (CW 2.16 AND CCW 2.06). PAIRED TO COMMERCIAL APP USING 22.5 UNITS. INPEN BASELINE AND WIRELESS FUNCTIONALITY. APP LOGBOOK DISPLAYED: 15,15,15,15,15,15,15,15,15,15. KNOB WAS CUT TO REVEAL ELECTRONICS HOUSING. NO SIGNS OF ABRASION WERE FOUND. ENCODER BASE BOND WAS INTACT. NO ADDITIONAL PROBLEMS FOUND WITH THIS INPEN. INJECTION FOOT DAMAGE WAS NOT CONFIRMED. LEADSCREW ANOMALY WAS NOT CONFIRMED. DOSE LOG INACCURACY WAS NOT CONFIRMED. HOWEVER, DIAL MISALIGNMENT WAS CONFIRMED WHICH COULD POTENTIALLY CAUSE INACCURATE DOSES TO APPEAR. CAP ANOMALY WAS 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

    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 THAT THE BLACK DISC BROKE OFF THE INJECTION FOOT. IT WAS ALSO REPORTED THAT THE DOSE KNOB/DIAL MISALIGNMENT WAS GREATER THAN 1.0 UNIT. TROUBLESHOOTING WAS PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE THE USE OF THE INPEN AND WILL BE RETURNED FOR ANALYSIS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1533610 INPEN MMT-105NNBLNA NOVO NORDISK BLUE SYRINGE, PISTON FMF COMPANION MEDICAL INC MMT-105NNBLNA B1602 000010862088000344

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Male