BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 16145647 · Received January 12, 2023

    Report

    Report Number
    2032227-2023-105686
    Event Type
    Malfunction
    Date Received
    January 12, 2023
    Date of Event
    March 7, 2022
    Report Date
    January 12, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000384289
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). S/W VER. 6.5W, RETAINER RING = BLACK, CASE TYPE = NGP. ON (B)(6) 2022 THE CUSTOMER REPORTED DEVICE NOT FOUND ERRORS. INSERTED A TEST P-CAP INTO THE RETAINER RING, AND IT LOCKED IN PLACE PROPERLY. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: CRACKED MIDDLE (ENTER) KEYPAD BUTTON. THE RETAINER RING IS SOLIDLY ATTACHED TO THE RESERVOIR TUBE LIP. DID NOT NOTE ANY CRACKS IN OR AROUND THE RESERVOIR TUBE LIP, OR IN THE RETAINER RING. DID NOT NOTE ANY CRACKS IN THE BATTERY TUBE OR IN THE BATTERY THREADS. THE UNIT PASSED DISPLACEMENT, REWIND, PRIME/SEATING, BASIC OCCLUSION, FORCE SENSOR, OCCLUSION, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, AND SELF TESTS. THE UNIT WAS PROGRAMMED WITH A TEST GUARDIAN LINK GL3 TRANSMITTER AND A GLUCOSE SENSOR SIMULATOR. THE UNIT CONNECTED SUCCESSFULLY TO THE TRANSMITTER AND DISPLAYED ¿PAIRING SUCCESSFUL¿. THE UNIT WAS THEN CALIBRATED, AND AFTERWARDS DISPLAYED THE SENSOR VALUES IN A GRAPH. NO UNEXPECTED SENSOR ERRORS OR CONNECTION ANOMALIES WERE NOTED. IN PARTICULAR NO DEVICE NOT FOUND ERRORS WERE SEEN DURING TESTING. THUS SOFTWARE WAS UTILIZED AND UPLOADED TRACE/HISTORY FILES PROPERLY. THE ADAPT TOOL CONFIRMS MULTIPLE OCCURRENCES OF THE FOLLOWING COMMUNICATION RELATED ALERTS/ALARMS AROUND THE EVENT DATE: 780,LOST SENSOR 1--10+ OCCURRENCES ON (B)(6) 2022; 781, LOST SENSOR 2--6 OCCURRENCES ON (B)(6) 2022; 796, SENSOR SIGNAL NOT FOUND OCCURRED ON (B)(6) 2022 @ 00:25:00. THE ADAPT TOOL DOES NOT LIST ANY PUMP ERRORS THAT COULD POTENTIALLY TRIGGER A CRITICAL PUMP ERROR WHATSOEVER. AFTER VISUAL INSPECTION, DID NOT NOTE ANY SIGNS OF PREVIOUS MOISTURE PRESENCE OR CORROSION INSIDE THE BATTERY COMPARTMENT OR ON ANY OF THE BOARDS, ASSEMBLIES, AND THE MOTOR INSIDE THE UNIT. IN SUMMARY, THE CUSTOMER¿S REPORT OF DEVICE NOT FOUND ERRORS WAS NOT 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

    MEDTRONIC RECEIVED INFORMATION THAT NO COM PUMP TO XMTR-UNRESOLVED, LOST SENSOR ALARM OCCURRED. THERE WAS NO ADVERSE IMPACT OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572878 MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MG/DL ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1886 000000763000384289

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown