BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INPEN MMT-105NNBLNA NOVO NORDISK BLUE

    MDR report key: 14071842 · Received April 11, 2022

    Report

    Report Number
    3012822846-2022-00605
    Event Type
    Malfunction
    Date Received
    April 11, 2022
    Date of Event
    March 21, 2022
    Report Date
    April 21, 2022
    Manufacturer
    COMPANION MEDICAL INC
    Product Code
    FMF
    UDI-DI
    000010862088000344
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PER VISUAL INSPECTION: CARTRIDGE HOLDER IS BROKEN AND DEBRIS/DUST FOUND UNDER DOSE WINDOW. CUSTOMER REPORT: LEADSCREW IS NOT MOVING AS INTENDED. SEVERAL ATTEMPTS WERE MADE TO PAIR INPEN, EVERY TIME APP DISPLAYED DOSE DOESN'T MATCH. THE INPEN DOES NOT PAIR WITH COMMERCIAL MOBILE APP. INPEN RECEIVED FULLY RE-WOUND. HARD TO DIAL MORE THAN 2 UNITS. THE INJECTION BUTTON WAS REMOVED AND FOUND DUST / DEBRIS UNDER THE DOSE BUTTON OR DOSE KNOB NOTED. INPEN DOSE BUTTON WAS REMOVED AND ELECTRONIC STACK, FLEX CONNECTOR AND BATTERY WERE INSPECTED FOR ELECTRICAL FAULTS, MOISTURE DAMAGE, WORKMANSHIP AND CRACKED OR DAMAGE COMPONENTS. ELECTRONICS WERE FOUND WITH CONTAMINATION (SAND OR DIRT GRAINS). A BATTERY TEST WAS PERFORMED AND THE BATTERY MEASURED AT 3.0 VOLTS. INPEN WAS CUT OPEN AND AFTER INSPECTION EVIDENCE WAS FOUND THAT THE ENCODER PATTERN WHEEL TABS ROTATING AND INTERMITTENT TRAVELING OFF THE KEYED SLOTS OF DOSE NUT GUIDES. ALSO EXCESSIVE PLASTIC SHAVINGS CONTAMINATION BUILD UP FOUND CAUSED BY ENCODER WHEEL TABS RUBBING AT THE WALLS OF THE DOSE NUT. IN CONCLUSION: : INPEN RECEIVED WITH BROKEN OFF PIECE AT THE CARTRIDGE HOLDER. CONTAMINATION 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 INPEN NOT TO PAIR OR INACCURACIES. IT WAS DETERMINED FROM DESTRUCTIVE ANALYSIS THAT THE LEADSCREW ANOMALY WAS CAUSED BY A PATTERN WHEEL MISALIGNMENT DUE TO AN ENCODER BASE BOND FAILURE AND CONTAMINATION. THIS CAN AFFECT INSULIN DELIVERY. THEREFORE, LEADSCREW ANOMALY IS 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

    SERIAL NUMBER: N/A. SOFTWARE VERSION: N/A. COLOR: BLUE. BATTERY LIFE REMAINING: N/A. PER VISUAL INSPECTION: CARTRIDGE HOLDER IS BROKEN AND DEBRIS/DUST FOUND UNDER DOSE WINDOW. CUSTOMER REPORT: LEADSCREW IS NOT MOVING AS INTENDED. SEVERAL ATTEMPTS WERE MADE TO PAIR INPEN, EVERY TIME APP DISPLAYED DOSE DOESN'T MATCH. THE INPEN DOES NOT PAIR WITH COMMERCIAL MOBILE APP. INPEN RECEIVED FULLY RE-WOUND. HARD TO DIAL MORE THAN 2 UNITS. THE INJECTION BUTTON WAS REMOVED AND FOUND DUST / DEBRIS UNDER THE DOSE BUTTON OR DOSE KNOB NOTED. INPEN DOSE BUTTON WAS REMOVED AND ELECTRONIC STACK, FLEX CONNECTOR AND BATTERY WERE INSPECTED FOR ELECTRICAL FAULTS, MOISTURE DAMAGE, WORKMANSHIP AND CRACKED OR DAMAGE COMPONENTS. ELECTRONICS WERE FOUND WITH CONTAMINATION (SAND OR DIRT GRAINS). A BATTERY TEST WAS PERFORMED AND THE BATTERY MEASURED AT 3.0 VOLTS. INPEN WAS CUT OPEN AND AFTER INSPECTION EVIDENCE WAS FOUND THAT THE ENCODER PATTERN WHEEL TABS ROTATING AND INTERMITTENT TRAVELING OFF THE KEYED SLOTS OF DOSE NUT GUIDES. ALSO EXCESSIVE PLASTIC SHAVINGS CONTAMINATION BUILD UP FOUND CAUSED BY ENCODER WHEEL TABS RUBBING AT THE WALLS OF THE DOSE NUT. IN CONCLUSION: : INPEN RECEIVED WITH BROKEN OFF PIECE AT THE CARTRIDGE HOLDER. CONTAMINATION 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 INPEN NOT TO PAIR OR INACCURACIES. IT WAS DETERMINED FROM DESTRUCTIVE ANALYSIS THAT THE LEADSCREW ANOMALY WAS CAUSED BY A PATTERN WHEEL MISALIGNMENT DUE TO AN ENCODER BASE BOND FAILURE AND CONTAMINATION. THIS CAN AFFECT INSULIN DELIVERY. THEREFORE, LEADSCREW ANOMALY IS 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 INPEN SCREW WAS NOT MOVING AS INTENDED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. TROUBLESHOOTING WAS SUCCESSFULLY PERFORMED; HOWEVER, THE CUSTOMER WILL DISCONTINUE USE OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329163 INPEN MMT-105NNBLNA NOVO NORDISK BLUE SYRINGE, PISTON FMF COMPANION MEDICAL INC MMT-105NNBLNA B0137 000010862088000344

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male