BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUARDIAN LINK 3 US

    MDR report key: 14509798 · Received May 26, 2022

    Report

    Report Number
    2032227-2022-195232
    Event Type
    Malfunction
    Date Received
    May 26, 2022
    Date of Event
    May 18, 2022
    Report Date
    May 25, 2022
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    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)(4). CUSTOMER CONCERN: REPORTING LOSS COMM DOP114-980DOC: LOSS OF COMMUNICATION/BG NOT RECEIVED/NO CALIBRATION OCCURRED DOCUMENT SYSTEM MODEL NUMBER: 770G DOCUMENT TRANSMITTER MODEL: GT8021833N CUSTOMER REPORTS LOSS OF COMMUNICATION BETWEEN PUMP AND TRANSMITTER (E.G. CANNOT FIND SENSOR SIGNAL, LOST SENSOR SIGNAL, CHECK CONNECTION, SENSOR SIGNAL NOT FOUND). DOCUMENT WHAT ALARM(S) CUSTOMER RECEIVED: LOST SENSOR SIGNAL DOCUMENT WHAT EVENT(S)/ACTIVITY(IES) OCCURRED BEFORE THE LOSS OF COMMUNICATION BEGAN: NONE IS CUSTOMER REPORTING BG NOT RECEIVED/NO CALIBRATION OCCURRED MESSAGE?: NO. IS THE CORRECT TRANSMITTER ID PROGRAMMED INTO PUMP?: NO IS THIS THE FIRST TIME CUSTOMER IS WIRELESSLY CONNECTING CURRENT TRANSMITTER TO PUMP?: NO WAS TRANSMITTER SERIAL NUMBER INTENTIONALLY REMOVED FROM CONNECTED DEVICES?: YES DOCUMENT HOW TRANSMITTER SERIAL NUMBER WAS REMOVED AND REASON FOR REMOVAL: OOW ADVISE CUSTOMER TO MONITOR PRODUCT. ADVISE CUSTOMER TO MONITOR BGS. ADVISE CUSTOMER TO CALL BACK AS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2772576 GUARDIAN LINK 3 US ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC MINIMED MMT-7911NA 1004098

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female