BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 16020862 · Received December 21, 2022

    Report

    Report Number
    2032227-2022-383521
    Event Type
    Malfunction
    Date Received
    December 21, 2022
    Date of Event
    September 21, 2022
    Report Date
    December 21, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). ON 9/21/2022 CUSTOMER CALLED IN WITH THE FOLLOWING CONCERN: PUMP WILL SHUT OFF AND RESET ITSELF AND PATIENT HAD TO RESET TIME AND DATE AND INFUSION SET. P-CAP LOCKED IN PLACE PROPERLY DURING TESTING. UNIT WAS SUCCESSFULLY DOWNLOADED USING (THUMP SOFTWARE). THE ADAPT TOOL WAS UTILIZED TO SEARCH FOR ALARMS THAT MAY HAVE OCCURRED IN THE PAST OR DURING COMPLAIN CALL THAT MIGHT OF TRIGGER THE REASON COMPLAIN. UNIT PASSED THE DISPLACEMENT TEST, REWIND, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST, OCCLUSION TEST AND SELF TEST. AUDIO OPTIONS SCREEN WAS SET TO LOW AND HIGH VOLUME AND ALL VOLUME SETTINGS FUNCTIONING ACCORDINGLY TO SETTINGS. NO VOLUME ANOMALIES NOTED DURING TESTING. NO PUMP ERROR 63 ALARM NOTED DURING TESTING. HOWEVER, ON 09/08/2022 AT 21:24:52 HOUR A PUMP ERROR 63 WAS RECORDED. FILE NUMBER=2017 LINE NUMBER=147. PER SOFTWARE ENGINEERING LOG INVESTIGATION PUMP ERROR 63 WAS CAUSE BY TWI INTERFACE ON MAIN/MOTOR PROCESSOR ESF# (3926945). PROBLEM ISOLATED TO ELECTRONIC ASSEMBLIES. UNIT WAS CUT OPEN AND PERFORM A VISUAL INSPECTION ON CONNECTORS AND ELECTRONIC ASSEMBLIES. PER VISUAL INSPECTION ALL CONNECTORS INCLUDING MOTOR FLEX CONNECTOR WERE PLUGGED IN PROPERLY. NO MOISTURE DAMAGE NOTED DURING VISUAL INSPECTION. UNIT RECEIVED WITH CRACKED KEYPAD AT SELECT BUTTON. IN CONCLUSION, NO UNEXPECTED RESET OR SHUTTING OFF NOTED DURING TESTING. HOWEVER, DURING DOWNLOAD REVIEW PUMP ERROR 63 ALARM NOTED. PROBLEM ISOLATED TO ELECTRONIC ASSEMBLY. 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 SHUTS OFF AND RESET ITSELF. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2143220 MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1880 HG4XPBEZZ

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Male