BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INPEN MMT-105NNBLNA NOVO NORDISK BLUE

    MDR report key: 17387465 · Received July 25, 2023

    Report

    Report Number
    3012822846-2023-01323
    Event Type
    Injury
    Date Received
    July 25, 2023
    Date of Event
    June 14, 2023
    Report Date
    November 13, 2023
    Manufacturer
    COMPANION MEDICAL INC
    Product Code
    FMF
    PMA / PMN Number
    K201337
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INPEN DID NOT PAIR WITH COMMERCIAL APP. INPEN DID NOT TRANSMIT TO MANUFACTURING APP. PERFORMED ENCODER BOND INVESTIGATION AND 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. ALSO, PLASTIC SHAVINGS CONTAMINATION BUILDS UP FOUND CAUSED BY ENCODER WHEEL TABS RUBBING AT THE WALLS OF THE DOSE NUT. ABRASIONS DOWN THE LENGTH OF THE DOSE NUT. UNABLE TO PERFORM BASELINE/WIRELESS FUNCTIONALITY AND DISPLACEMENT DOSE ACCURACY TEST. INPEN PASSED FRONT CAP INVESTIGATION. IN CONCLUSION: IT WAS DETERMINED FROM DESTRUCTIVE ANALYSIS THAT THE DIFFICULT TO DIAL/DOSE WAS CAUSED BY A PATTERN WHEEL MISALIGNMENT DUE TO AN ENCODER BASE BOND FAILURE. THIS CAN AFFECT INSULIN DELIVERY. THEREFORE, DIFFICULT TO DIAL/DOSE WAS CONFIRMED. UNABLE TO CONFIRM DOSE LOG INACCURACY DUE TO DIFFICULT TO DIAL/DOSE. 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.

    Additional Manufacturer Narrative · 0

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND 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 EXPERIENCED HYPERGLYCEMIA WITH A BLOOD GLUCOSE VALUE OF 400+ MG/DL AND REPORTED THAT THE INSULIN PEN DOSAGE WAS SHOWING INCORRECTLY, THE DOSE AMOUNT APPLICATION RECORDED WAS DIFFERENT THAN WHAT IS DIALED ON THE INPEN. TROUBLESHOOTING WAS PERFORMED AND FOUND THAT THE CUSTOMER WAS TREATED WITH A MANUAL INJECTION. THE CUSTOMER WAS NOT REPORTING ANY SYMPTOMS RELATED TO HIGH BLOOD GLUCOSE EVENT. THE DIFFERENCE BETWEEN THE DOSE INTENDED AND DOSE LOGGED WAS GREATER THAN 0.5 UNITS. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE CUSTOMER WILL DISCONTINUE USING THE INPEN. THE INPEN WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632515 INPEN MMT-105NNBLNA NOVO NORDISK BLUE SYRINGE, PISTON FMF COMPANION MEDICAL INC MMT-105NNBLNA

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Male Other