BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INPEN MMT-105NNBLNA NOVO NORDISK BLUE

    MDR report key: 15535617 · Received October 4, 2022

    Report

    Report Number
    3012822846-2022-01444
    Event Type
    Malfunction
    Date Received
    October 4, 2022
    Date of Event
    July 22, 2022
    Report Date
    October 4, 2022
    Manufacturer
    COMPANION MEDICAL INC
    Product Code
    FMF
    UDI-DI
    000010862088000344
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    COLOR: BLUE. CUSTOMER REPORT: THE PEN DIAL DOES NOT TURN PAST 5 UNITS. PER VISUAL INSPECTION: NO PHYSICAL DAMAGE TO CAP, CARTRIDGE HOLDER OR INPEN WAS NOTED. SEVERAL ATTEMPTS WERE MADE TO PAIR INPEN, EVERY TIME APP DISPLAYED DOSE DOESN'T MATCH. THE INPEN DOES NOT PAIR WITH COMMERCIAL MOBILE APP. RECEIVED INPEN 1/4 OF TRAVEL. RE-WOUND PEN. UNABLE TO DIAL MORE THAN 2.5 UNITS. THE DOSE BUTTON WAS REMOVED AND DUST / DEBRIS UNDER THE DOSE BUTTON OR DOSE KNOB WAS NOTED. INPEN WAS CUT OPEN AND AFTER INSPECTION IT WAS FOUND THAT THE ENCODER PATTERN WHEEL TABS ROTATING AND TRAVELING OFF THE KEYED SLOTS OF DOSE NUT GUIDES. ENCODER PATTERN WHEEL SHOULD NEVER ROTATE. THIS CAUSES AN UNEXPECTED TRAVEL OF THE ENCODER PATTERN WHEEL CREATING RESISTANCE TO DIAL AND DISPENSING. UNABLE TO PERFORM FUNCTIONAL TEST DUE TO LEADSCREW ANOMALY. IN CONCLUSION: IT WAS DETERMINED FROM DESTRUCTIVE ANALYSIS THAT THE LEADSCREW ANOMALY WAS CAUSED BY A PATTERN WHEEL MISALIGNMENT DUE TO AN ENCODER BASE BOND FAILURE. THIS CAN AFFECT INSULIN DELIVERY. BROKEN ENCODER BOND CAN CAUSE THE ENCODER TO NOT MAKE ELECTRICAL CONNECTIONS THEREFORE, MISSING A COUNT OR IF THERE IS A SHORT, YOU MAY HAVE EXTRA PULSES WHICH WILL CAUSE INACCURACY OR INPEN NOT PARING. THEREFORE, THE CUSTOMER COMPLAINT OF LEADSCREW 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.

    Description of Event or Problem · 0

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PEN WAS NOT WORKING PROPERLY. CUSTOMER STATED THAT THE INSULIN PEN DIAL DID NOT TURN PAST 5 UNITS. CUSTOMER STATED THAT DIAL INSULIN WAS BROKEN OR DAMAGED OR NOT WORKING CORRECTLY. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2934187 INPEN MMT-105NNBLNA NOVO NORDISK BLUE SYRINGE, PISTON FMF COMPANION MEDICAL INC MMT-105NNBLNA B0328 000010862088000344

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male