BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUARDIAN LINK 3 US

    MDR report key: 15068035 · Received July 20, 2022

    Report

    Report Number
    2032227-2022-295408
    Event Type
    Malfunction
    Date Received
    July 20, 2022
    Date of Event
    June 16, 2022
    Report Date
    July 20, 2022
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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. DEVICE WAS PUT TO CHARGE FOR +2 HOURS. THE GANG CHARGER SHOWED TRANSMITTER WAS STILL CHARGING AFTER SEVERAL HOURS AND DID NOT DETECT TRANSMITTER REACHING FULL CHARGE. VOLTAGE AFTER CHARGE WAS AT 0.10 VOLT. IN CONCLUSION, UNABLE TO CHARGE DEVICE DUE TO DEPLETED BATTERY. THE CUSTOMER COMPLAINT OF TRANSMITTER NOT CHARGING IS CONFIRMED. 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 INSULIN PUMP HAD BATTERY UNABLE TO LAST CHARGE ISSUES ON THE TRANSMITTER. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2354808 GUARDIAN LINK 3 US ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC MINIMED MMT-7911NA 1056077

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male