BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUARDIAN LINK 3 US

    MDR report key: 16944104 · Received May 17, 2023

    Report

    Report Number
    2032227-2023-207533
    Event Type
    Injury
    Date Received
    May 17, 2023
    Date of Event
    February 2, 2023
    Report Date
    May 17, 2023
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZP
    PMA / PMN Number
    P160017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). UNIT WAS ABLE TO CHARGE PROPERLY. UNIT FAILED TO COMMUNICATE AND SYNC DURING RF/BLE ASSOCIATION. UNABLE TO PERFORM FUNCTIONAL TEST DUE TO COMMUNICATION ANOMALY. NO MOISTURE DAMAGE OR PHYSICAL DAMAGE TO CONNECTOR PINS, COW CATCHER, OR CASE WAS NOTED PER VISUAL INSPECTION. IN CONCLUSION, IT WAS DETERMINED THAT COMMUNICATION ANOMALY WAS ISOLATED TO ELECTRONIC ASSEMBLY. UNABLE TO CONFIRM ALLEGATIONS OF HIGH BGS AND SG V BG ALERT. 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 BIG DISCREPANCY BETWEEN SENSOR AND BLOOD GLUCOSE VALUES AND EXPERIENCED HYPERGLYCEMIA WITH A BLOOD GLUCOSE VALUE OF 400 MG/DL AT THE TIME OF THE EVENT.  TROUBLESHOOTING WAS PERFORMED AND IT WAS AN UNKNOWN WHETHER THE CUSTOMER HAD BEEN USING THE INSULIN PUMP SYSTEM WITHIN 48 HOUR. IT WAS ALSO FOUND THAT THE AUTO MODE FEATURE WAS ACTIVE AT THE TIME OF THE EVENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE CUSTOMER WILL CONTINUE THE USE OF THE INSULIN PUMP AND THE TRANSMITTER WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602776 GUARDIAN LINK 3 US AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC MINIMED MMT-7911NA 1080192

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Female Other