BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INPEN MMT-105NNPKNA NOVO NORDISK PINK

    MDR report key: 16159952 · Received January 13, 2023

    Report

    Report Number
    3012822846-2023-00115
    Event Type
    Malfunction
    Date Received
    January 13, 2023
    Date of Event
    May 8, 2022
    Report Date
    January 13, 2023
    Manufacturer
    COMPANION MEDICAL INC
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SERIAL NUMBER: (B)(4), SOFTWARE VERSION: 3.8.4. COLOR: PINK. BATTERY LIFE REMAINING: <6 MONTHS. PER VISUAL INSPECTION: DOSE WINDOW IS MISSING. NO PHYSICAL DAMAGED TO CAP AND CARTRIDGE HOLDER WAS NOTED. CUSTOMER REPORTS: DOSE DIAL DOES NOT TURN PAST 10 UNITS. THE INPEN PAIRED TO THE COMMERCIAL APP WITH SMALL PAIRING DOSE. LEADSCREW WAS RECEIVED FULLY EXTENDED. IT WAS RE-WOUND AND RESISTANCE WAS NOTED. HIGH RESISTANCE WAS NOTED WHILE TRYING TO DIAL A DOSE AND DIAL GETS INTERMITTENTLY JAMMED. HARD TO DIAL MORE THAN 4 UNITS. UNABLE TO PERFORM FUNCTIONAL TEST DUE TO LEADSCREW ANOMALY. IN CONCLUSION: PER DENNIS BERG SAN DIEGO INVESTIGATION: TANGLED DOSE CENTERING SPRING. THIS CAN AFFECT INSULIN DELIVERY. THEREFORE, THE CUSTOMER COMPLAINT OF LEADSCREW ANOMALY WAS CONFIRMED DUE TO TANGLED SPRING. 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

    MEDTRONIC RECEIVED INFORMATION THAT DAMAGE (PHYSICAL OR COSMETIC) OCCURRED. THERE WAS NO ADVERSE IMPACT OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1464691 INPEN MMT-105NNPKNA NOVO NORDISK PINK SYRINGE, PISTON FMF COMPANION MEDICAL INC MMT-105NNPKNA B93DE

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Unknown