BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSMITTER MMT-7841ZW GST5G OUS

    MDR report key: 15063924 · Received July 20, 2022

    Report

    Report Number
    2032227-2022-294988
    Event Type
    Malfunction
    Date Received
    July 20, 2022
    Date of Event
    June 26, 2022
    Report Date
    July 20, 2022
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. 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

    (B)(6) 2022 18:21:33 PST ICE BATCH USER (BATCH_ICE) PHONE (B)(6) COMPLAINT: (B)(4). COMPLAINT STATUS: CUSTOMER ACTION MDT INITIAL CONTACT: DIANA CAROLINA VILLACRES REDROVAN TAKEN BY: REDROD2 ALBA MMT-7040C1 HG5ZYQH ARM KT1179318N PAT'S MOM CALLS BECAUSE SINCE SUNDAY THEY HAVE RECEIVED LOST SENSOR AND CHANGE SENSOR ALERT. THEY HAVE LOST 3 SENSOR IN TOTAL AND AFTER UNPAIR THE XMTR WITH THE PUMP THEY COULDN'T PAIR THEM AGAIN. MOM IS NOT WITH PAT + PUMP + XMTR, SO THEY WILL CALL US BACK LATER TO FINISH THE TS AND TEST THE XMTR. COUNTRY: SPAIN CITY: VALDELACALZADA ZIP: (B)(6) INPUT DATE: (B)(6) 2022 WARRANTY START: (B)(6) 2021 WARRANTY END: 10/12/2100 BATCH - (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2611906 TRANSMITTER MMT-7841ZW GST5G OUS SENSOR, GLUCOSE, INVASIVE MDS MEDTRONIC MINIMED MMT-7841ZW 1033499

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown