BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INPEN MMT-105NNPKNA NOVO NORDISK PINK

    MDR report key: 17893661 · Received October 9, 2023

    Report

    Report Number
    3012822846-2023-01666
    Event Type
    Malfunction
    Date Received
    October 9, 2023
    Date of Event
    September 12, 2023
    Report Date
    November 9, 2023
    Manufacturer
    COMPANION MEDICAL INC
    Product Code
    FMF
    UDI-DI
    0000108620880003
    PMA / PMN Number
    K201337
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PAIRED TO COMMERCIAL APP USING 11 UNITS. INPEN BASELINE AND WIRELESS FUNCTIONALITY. APP LOGBOOK DISPLAYED: 15,15,15,14.5,15,15,15,15,15,15 KNOB WAS CUT TO REVEAL ELECTRONICS HOUSING. NO SIGNS OF ABRASION WERE FOUND. ENCODER BASE BOND WAS STILL INTACT. NO PROBLEMS FOUND WITH THIS INPEN ALL FUNCTIONS TESTED OK CUSTOMER REPORTS: SCREW IS NOT MOVING AS INTENDED AND DIFFICULT TO DIAL/DOSE. PER VISUAL INSPECTION: FRONT SHELL DOES NOT FIT SECURELY ONTO INPEN. NO PHYSICAL DAMAGE TO CARTRIDGE HOLDER OR INPEN FRONT AND BACK SHELL WAS NOTED. CARTRIDGE HOLDER LOCKS PROPERLY IN PLACE. UNIT PAIRED SUCCESSFULLY TO COMMERCIAL APP. UNIT PASSED BASELINE AND WIRELESS FUNCTIONALITY. APP LOGBOOK DISPLAYED: 15U, 15U, 15U, 15U, 15U, 15U, 15U, 15U, 15U, 15U. INPEN PASSED LEADSCREW RESET TORQUE TEST. UNIT WITHIN SPECIFICATION (CW: 0.40 OZF-IN AND CCW: 4.35 OZF-IN). 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 LOCATION: INPEN PASSED BASE LINE FUNCTIONALITY TEST AND DISPLACEMENT DOSE ACCURACY. INPEN PASSED LEADSCREW RESET TORQUE (TORQUE CW 2.75 AND CCW 2.38). PAIRED TO COMMERCIAL APP USING 11 UNITS. INPEN BASELINE AND WIRELESS FUNCTIONALITY. APP LOGBOOK DISPLAYED: 15,15,15,14.5,15,15,15,15,15,15. KNOB WAS CUT TO REVEAL ELECTRONICS HOUSING. NO SIGNS OF ABRASION WERE FOUND. ENCODER BASE BOND WAS STILL INTACT. NO PROBLEMS FOUND WITH THIS INPEN ALL FUNCTIONS TESTED OK. 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. 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. 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'S INPEN SCREW WAS NOT MOVING AS INTENDED. TROUBLESHOOTING WAS PERFORMED REPORTS SCREW IS NOT MOVING AS INTENDED. NO FURTHER PATIENT COMPLICATIONS WERE 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
    1121224 INPEN MMT-105NNPKNA NOVO NORDISK PINK SYRINGE, PISTON FMF COMPANION MEDICAL INC MMT-105NNPKNA B0870 0000108620880003

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female