BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR MMT-7040A GUARDIAN4 5PK US

    MDR report key: 17981628 · Received October 21, 2023

    Report

    Report Number
    2032227-2023-287670
    Event Type
    Malfunction
    Date Received
    October 21, 2023
    Date of Event
    September 27, 2023
    Report Date
    December 8, 2023
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZP
    PMA / PMN Number
    P160017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATED 1 OPEN/USED 1 CLICK ENLITE-SERTER, AN INSERTION TEST IS PERFORMED. FOR TEST: USING A NEW LABORATORY GUARDIAN SENSOR IN THE SERTER; THE SENSOR IS CHARGED AGAINST THE PEDESTAL AND THE INSERTION IS CARRIED OUT INTO AN ARTIFICIAL TORSO, PRESSING THE RELEASE BUTTONS; THE 1-CLICK ENLITE SERTER WENT THROUGH THE INSERTION TEST, THE GUARDIAN SENSOR RELEASE/INSERT NEEDLE, AND THE SENSOR LINER PROPERLY. PER DOP114-811DOC: APPENDIX B. CONCLUSION: THE INSERTION TEST REVEALS THE ENLITE-SERTER RELEASE THE GUARDIAN SENSOR AND THE INSERTION NEEDLE PROPERLY. 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

    FOLLOWING OUR RECEIPT OF THE ONE RETURNED USED SENSOR AND PERFORMED VISUAL INSPECTION AND FOUND NEEDLE SEPARATED FROM SENSOR BASE. INSPECTED INSERTION NEEDLE FOR BURRS/HOOKS AND DULL NEEDLE TIP DEFECTS AND NONE WERE FOUND. INTRODUCER NEEDLE PASSED PER SPECIFICATIONS. UNABLE TO CONFIRM INSERTION ANOMALY DUE TO SENSOR BEING USED. IN SUMMARY, THE CUSTOMER COMPLAINT OF INSERTION ANOMALY COULD NOT BE CONFIRMED. BECAUSE THE SENSOR WAS ALREADY OPENED OR USED WHEN WE RECEIVED IT FOR TESTING, IT IS IMPOSSIBLE TO DETERMINE WHEN OR HOW THIS HAPPENED. 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 REPORTED ISSUE WITH ONE PRESS SERTER. TROUBLESHOOTING WAS PERFORMED .NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DIS CONTINUE USING THE DEVICE AND THE DEVICE WILL BE RETURNED ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2038309 SENSOR MMT-7040A GUARDIAN4 5PK US AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC MINIMED MMT-7040A

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male