BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XMTR MMT-7811XWW GST3C OUS

    MDR report key: 15143917 · Received August 2, 2022

    Report

    Report Number
    2032227-2022-304662
    Event Type
    Malfunction
    Date Received
    August 2, 2022
    Date of Event
    April 19, 2022
    Report Date
    January 11, 2023
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    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.

    Additional Manufacturer Narrative · 0

    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. INITIAL REPORT WAS SUBMITTED WITH MISSING INFORMATION. THE CORRECTED INFORMATION HAS BEEN UPDATED AND PROVIDED WITH THIS REPORT IN SECTION B5. OCCUPATION HAS BEEN UPDATED AND PROVIDED WITH THIS REPORT IN SECTION E3. REPORT SOURCE HAS BEEN UPDATED AND PROVIDED WITH THIS REPORT IN SECTION G2.

    Description of Event or Problem · 0

    (B)(6) 2022 17:24:26 PST ICE BATCH USER (BATCH ICE) PHONE (B)(6) COMPLAINT: (B)(4) COMPLAINT STATUS: IN PROCESS MDT INITIAL CONTACT: (B)(6) TAKEN BY: CADEF2 INQUIRED WHAT LED UP TO THE COMPLAINT. CUSTOMER RESPONSE: PATIENT CALLS TO PAIR PUMP WITH TRANSMITTER. DEVICE CUSTOMER IS ATTEMPTING TO PAIR WITH THE PUMP: TRANSMITTER. IS DEVICE IN QUESTION COMPATIBLE WITH THE PUMP¿S BLUETOOTH WIRELESS TECHNOLOGY: NO HAS PUMP PREVIOUSLY BEEN PAIRED WITH DEVICE IN QUESTION: YES IS THE DEVICE IN QUESTION LISTED WITH MANAGE/PAIRED DEVICES SCREEN: NO. CONFIRMED CUSTOMER DELATE/UNPAIRED ANY EXISTING PAIRED TRANSMITTER. ADV CUSTOMER TO ATTACH TRANSMITETR TO THE CHARGER AND MAKE SURE THE TRANSMITTER IS FULLY CHARGED AND TO KEEP TRANSMITTER ATTACHED TO CHARGER AND NEXT TO THE PUMP. ADV CUSTOMER TO PREPARE THE PUMP TO PAIR WITH THE TRANSMITTER. DID PUMP ALERT WITH ¿DEVICE NOT FOUND¿:YES. SHIP: MMT-7811W1 / RETURN: NOTHING COUNTRY: ITALY CITY: (B)(6) ZIP: (B)(6) INPUT DATE: (B)(6) 2022 WARRANTY START: (B)(6) 2022 WARRANTY END: 04/17/2023 BATCH - GT8263851M.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CUSTOMER HAD ISSUES PAIRING WITH INSULIN PUMP AND TRANSMITTER. CUSTOMER RECEIVED DEVICE NOT FOUND ALERT. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER WILL CONTINUE USING THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358495 XMTR MMT-7811XWW GST3C OUS ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC MINIMED MMT-7811WW A000844439

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown