BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INPEN MMT-105NNBLNA NOVO NORDISK BLUE

    MDR report key: 16157492 · Received January 13, 2023

    Report

    Report Number
    3012822846-2023-00069
    Event Type
    Malfunction
    Date Received
    January 13, 2023
    Date of Event
    April 21, 2022
    Report Date
    January 13, 2023
    Manufacturer
    COMPANION MEDICAL INC
    Product Code
    FMF
    UDI-DI
    000010862088000344
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SERIAL NUMBER: (B)(4). SOFTWARE VERSION: 3.8.5. COLOR: BLUE. BATTERY LIFE REMAINING: <6 MONTHS. PER VISUAL INSPECTION: CAP IS LOOSED AND DOSE WINDOW IS MISSING. NO PHYSICAL DAMAGE TO CARTRIDGE HOLDER WAS NOTED. CUSTOMER REPORTS: INPEN APP IS NOT RECORDING THE EXACT DOSES DIALED ON THE INPEN. THE INPEN PAIRED TO THE COMMERCIAL APP WITH SMALL PAIRING DOSE. MY INPEN MENU DISPLAYED: I DOSED 4.0U SLOWLY HOLDING KNOB AND BUTTON TOGETHER X 4 TIMES. THE APP RECORDED 0.5 U, 3.0U AND 3.0 U AND 2.0 U. THE LEADSCREW REWIND PROPERLY. THE LEADSCREW WAS NOT BENT, ADVANCED WHEN DOSAGE KNOB WAS PRESSED DIALING A DOSAGE AND RETRACTED APPROPRIATELY. NO RESISTANCE WAS OBSERVED WHEN DOSING WITHOUT A CARTRIDGE INSTALLED. THE SCREW ADVANCED EVERY TIME 30.0U WAS DIALED AND DOSED UNTIL THE SCREW REACHED MAX EXTENSION. IN CONCLUSION: PER SAN DIEGO INVESTIGATION: FALSE ENCODER READINGS WOULD OCCUR AT LARGER DOSE SIZES (29.5U). THE INPEN WAS DISSECTED TO INVESTIGATE THE ELECTRICAL SYSTEM. HOWEVER, DURING DISSECTION, THE FLEX PCBA WAS ACCIDENTALLY CUT SO ROOT CAUSE OF THE DOSE LOG INACCURACY COULD NOT BE DETERMINED. INPEN DID PRODUCE INACCURACY DOSE LOG. THEREFORE, THE CUSTOMER COMPLAINT OF DOSE LOG INACCURACY WAS CONFIRMED, HOWEVER UNABLE TO MEASURE ELECTRICAL CIRCUITRY AND FIND ROOT CAUSE BECAUSE ACCIDENTALLY DAMAGED DURING DECONSTRUCTIVE ANALYSIS. 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

    MEDTRONIC RECEIVED INFORMATION THAT DOSE LOG/REPORT DATA INACCURACY OCCURRED. THERE WAS NO ADVERSE IMPACT OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1065091 INPEN MMT-105NNBLNA NOVO NORDISK BLUE SYRINGE, PISTON FMF COMPANION MEDICAL INC MMT-105NNBLNA B0143 000010862088000344

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Unknown