BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INPEN MMT-105ELPKNA ELI LILY PINK

    MDR report key: 13573199 · Received February 21, 2022

    Report

    Report Number
    3012822846-2022-00137
    Event Type
    Injury
    Date Received
    February 21, 2022
    Date of Event
    February 13, 2022
    Report Date
    March 17, 2022
    Manufacturer
    COMPANION MEDICAL INC
    Product Code
    FMF
    UDI-DI
    000010862088000337
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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: PINK. BATTERY LIFE REMAINING: <4 MONTHS. PER VISUAL INSPECTION: MISSING DOSAGE WINDOW WAS NOTED. CUSTOMER REPORTS: HIGH BG AND UNEXPECTED NOISE FROM LEADSCREW. UNIT PAIRED SUCCESSFULLY TO COMMERCIAL APP. MY INPEN MENU DISPLAYED: THE FOLLOWING TEST VALUES WERE DIALED AND DOSED: 10 TEST VALUES OF 4.0U DIALED AND DOSED. ALL VALUES DISPLAYED ACCURATELY IN THE LOGBOOK. ALL DOSES WERE WRITTEN TO THE APP LOGBOOK WITHIN 1 MINUTE. INPEN RECEIVED WITH LEADSCREW 1/4 OF THE TRAVEL. THE SCREW 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: NO UNEXPECTED NOISE FROM LEADSCREW WAS FOUND DURING TESTING. INPEN RECEIVED WORKING AS DESIGN. NO MALFUNCTIONS NOTED DURING TESTING THAT COULD AFFECT INSULIN DELIVERY. CUSTOMER COMPLAIN OF LEADSCREW ANOMALY NOT 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

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 400 MG/DL. CUSTOMER STATED LEAD SCREW WAS MAKING A LOUD ODD NOISE. THE INSULIN PEN WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1079764 INPEN MMT-105ELPKNA ELI LILY PINK SYRINGE, PISTON FMF COMPANION MEDICAL INC MMT-105ELPKNA B94YE 000010862088000337

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Unknown Other