BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INPEN MMT-105NNGYNA NOVO NORDISK GRAY

    MDR report key: 13851546 · Received March 22, 2022

    Report

    Report Number
    3012822846-2022-00458
    Event Type
    Malfunction
    Date Received
    March 22, 2022
    Date of Event
    September 14, 2021
    Report Date
    March 21, 2022
    Manufacturer
    COMPANION MEDICAL INC
    Product Code
    FMF
    UDI-DI
    000010862088000351
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS PART OF A RETROSPECTIVE REVIEW AND REMEDIATION EFFORTS IN RESPONSE TO A WARNING LETTER. SERIAL NUMBER: (B)(4). SOFTWARE VERSION: 3.8.5. COLOR: GREY. BATTERY LIFE REMAINING: <5 MONTHS. CUSTOMER REPORTS: HER INPEN IS NOT LOGGING ALL OF HER DOSES. CUSTOMER WAS RECENTLY IN THE DESERT AND STATES SAND MIGHT HAVE GOTTEN IN HER INPEN. THE CLEAR PLASTIC DOSING WINDOW HAD COME OFF. PER VISUAL INSPECTION: MISSING DOSING WINDOW AND FADED NUMBER 2 AT THE DIAL. UNIT PAIRED SUCCESSFULLY TO COMMERCIAL APP. MY INPEN MENU DISPLAYED: THE FOLLOWING TEST VALUES WERE DIALED AND DOSED: 4.0U, 4.0U, 4.0U, 4.0U AND 16.0U. ALL VALUES DISPLAYED ACCURATELY IN THE LOGBOOK. ALL DOSES WERE WRITTEN TO THE APP LOGBOOK WITHIN 1 MINUTE. INPEN RECEIVED WITH LEADSCREW 3/4 OF THE TRAVEL. RE-WOUND SCREW. NO DRAG WAS OBSERVED, 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: THE PATIENT COMPLAINT OF DOSE LOG INACCURACIES OR TRACES OF SAND OR DUST AT THE DOSE KNOB / DOSE BUTTON COULD NOT BE CONFIRMED. HOWEVER, MISSING DOSING WINDOW COMPLAINT WAS CONFIRMED. PENDING FURTHER ANALYSIS THAT WILL BE PERFORM IN SAN DIEGO LOCATION. 2/11/2022 PER NETA GLASER, UNIT TESTED OK AND NO DOSE LOG ANOMALIES WERE WITNESS IN SAN DIEGO. THE CUSTOMER COMPLAINT COULD NOT BE DUPLICATED. 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
    2144400 INPEN MMT-105NNGYNA NOVO NORDISK GRAY SYRINGE, PISTON FMF COMPANION MEDICAL INC MMT-105NNGYNA B94JE 000010862088000351

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Unknown