BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XMTR MMT-7811NA GST3C LOCKOUT

    MDR report key: 16291088 · Received February 3, 2023

    Report

    Report Number
    2032227-2023-141933
    Event Type
    Injury
    Date Received
    February 3, 2023
    Date of Event
    July 18, 2021
    Report Date
    February 3, 2023
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS PART OF A RETROSPECTIVE REVIEW AND REMEDIATION. UPDATED ANALYSIS SUMMARY BY (B)(6) ON (B)(6) 2022. PATIENT RETURNED TRANSMITTER WITH ALLEGATION OF COMMUNICATION ANOMALY, HIGH BGS, NAUSEA, DKA, AND ADMITTANCE TO ER/HOSPITAL ON (B)(6) 2021. NO PHYSICAL DAMAGE TO CONNECTOR PINS, COW CATCHER OR CASE WAS NOTED PER VISUAL INSPECTION. NO TRACES OF MOISTURE / CONTAMINATION WERE NOTED AT CONNECTOR PER VISUAL INSPECTION. UNIT WAS ABLE TO CHARGE PROPERLY. UNIT PASSED FUNCTIONAL TEST INCLUDING RF AND ACCURACY TEST. UNABLE TO CONFIRM ALLEGATION OFF HIGH BGS, DKA, AND HOSPITALIZATION. 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 NO COM PUMP TO XMTR-UNRESOLVED OCCURRED. THERE WAS AN ALLEGATION OF FATIGUE, HYPERGLYCEMIA, NAUSEA, VOMITING AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403195 XMTR MMT-7811NA GST3C LOCKOUT SENSOR, GLUCOSE, INVASIVE MDS MEDTRONIC MINIMED MMT-7811NA A000823891

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Unknown Required Intervention