BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INPEN MMT-105NNGYNA NOVO NORDISK GRAY

    MDR report key: 17983232 · Received October 23, 2023

    Report

    Report Number
    3012822846-2023-01745
    Event Type
    Injury
    Date Received
    October 23, 2023
    Date of Event
    September 28, 2023
    Report Date
    October 23, 2023
    Manufacturer
    COMPANION MEDICAL INC
    Product Code
    FMF
    UDI-DI
    0000108620880003
    PMA / PMN Number
    K201337
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 FRONT AND BACK SHELL WAS NOTED. RETRACTING LEADSCREW WHEN DIALING. INPEN PAIRED TO THE COMMERCIAL APP. PERFORMED DUST/DEBRIS INVESTIGATION AND FOUND VISIBLE HORIZONTAL ABRASIONS AND STICKY FLUID ON THE OUTSIDE OF ELECTRONICS HOUSING. THIS INDICATED DEBRIS WAS LODGED BETWEEN THE DOSE KNOB AND ELECTRONICS HOUSING CAUSING THE LEADSCREW ANOMALY. PERFORMED LEADSCREW RESET TORQUE TEST. INPEN PASSED AND IS WITHIN SPECIFICATION (CW: 0.40 OZF-IN AND CCW: 5.60 OZF-IN). UNABLE TO PERFORM BASELINE/WIRELESS FUNCTIONALITY AND DISPLACEMENT DOSE ACCURACY TEST. INPEN FAILED FRONT CAP INVESTIGATION. INPEN FRONT SHELL DOES NOT FIT SECURELY ONTO CARTRIDGE HOLDER DUE TO SNAP ARM BEING CRACKED / BROKEN. 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 HIGH BG. 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 EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL AT THE TIME OF EVENT WAS 400 MG/DL. THE CUSTOMER DID NOT EXPERIENCE ANY SYMPTOMS OF HIGH BLOOD GLUCOSE VALUE. THE CUSTOMER TREATED HIGH BLOOD GLUCOSE WITH MANUAL INJECTION. THE CUSTOMER ALSO REPORTED THAT THE SCREW WAS NOT MOVING AS INTENDED AND NO INSULIN WAS DISPENSED WHEN THE INJECTION/DOSE BUTTON WAS PUSHED. TROUBLESHOOTING WAS PERFORMED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE INPEN WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    813247 INPEN MMT-105NNGYNA NOVO NORDISK GRAY SYRINGE, PISTON FMF COMPANION MEDICAL INC MMT-105NNGYNA B1456 0000108620880003

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Other