BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INPEN MMT-105ELBLNA ELI LILY BLUE

    MDR report key: 13677784 · Received March 7, 2022

    Report

    Report Number
    3012822846-2022-00197
    Event Type
    Malfunction
    Date Received
    March 7, 2022
    Date of Event
    March 2, 2022
    Report Date
    March 30, 2022
    Manufacturer
    COMPANION MEDICAL INC
    Product Code
    FMF
    UDI-DI
    000010862088000313
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    SERIAL NUMBER: (B)(6). SOFTWARE VERSION: 3.8.5. COLOR: BLUE. BATTERY LIFE REMAINING: <12 MONTHS. PER VISUAL INSPECTION: NO PHYSICAL DAMAGED TO CAP, CARTRIDGE HOLDER OR INPEN WAS NOTED. CUSTOMER REPORTS: DOSE DIAL DOES NOT TURN PAST 3 UNITS. THE INPEN PAIRED TO THE COMMERCIAL APP WITH SMALL PAIRING DOSE. LEADSCREW WAS RECEIVED FULLY RE-WOUNDED. HARD TO DIAL MORE THAN 4 UNITS. THE INJECTION BUTTON WAS REMOVED AND NO DUST / DEBRIS WAS 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. 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. THE CUSTOMER COMPLAINT OF HARD TO TURN DOSE DIAL OF INPEN 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 DOSE DIAL IS NOT TURNING PAST 3 UNITS. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE THE USE OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2689648 INPEN MMT-105ELBLNA ELI LILY BLUE SYRINGE, PISTON FMF COMPANION MEDICAL INC MMT-105ELBLNA B0209 000010862088000313

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female