BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 15922720 · Received December 6, 2022

    Report

    Report Number
    2032227-2022-370994
    Event Type
    Malfunction
    Date Received
    December 6, 2022
    Date of Event
    August 22, 2022
    Report Date
    December 6, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000414344
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). SOFTWARE VERSION 5.2A RETAINER RING=BLACK CUSTOMER COMPLAINED ON (B)(6) 2022 THE PUMP ALARMED PUMP ERROR 15. DEVICE PASSED ACTIVE CURRENT MEASUREMENT, SLEEP CURRENT MEASUREMENT TEST, SELFTEST, REWIND, SEATING, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST AND DISPLACEMENT TEST. NO PUMP ERROR 15 ALARMS NOTED DURING TESTING. UNIT SUCCESSFULLY DOWNLOADED TO THUMPS. HOWEVER, THE FORMATTED HISTORY FILE CONFIRMED THE PUMP ALARMED PUMP ERROR 15 ALARM (LINE NUMBER 1935 FILE NUMBER 0) ON 06/25/2022 09:36:09.000 DUE TO SOFTWARE ERROR AS PER GLOBAL LOGIC ANALYSIS (ESF3764385). NO MOISTURE DAMAGE NOTED TO ELECTRONIC ASSEMBLIES PER VISUAL INSPECTION. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: SCRATCHED CASE, PILLOWING KEYPAD OVERLAY, CRACKED CASE CORNER OF THE BELT CLIP RAILS NEAR THE BATTERY COMPARTMENT, CRACKED BATTERY TUBE THREADS AND CRACKED KEYPAD OVERLAY. THE P-CAP/RESERVOIR DOES LOCK PROPERLY. NO PUMP ERROR 15 ALARMS NOTED DURING TESTING AND CONFIRMED THE PUMP ALARMED PUMP ERROR 15 ALARM (LINE NUMBER 1935 FILE NUMBER 0) ON 06/25/2022 09:36:09.000 DUE TO SOFTWARE ERROR AS PER GLOBAL LOGIC ANALYSIS (ESF3764385). 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 A PUMP ERROR ALARM. CUSTOMER WAS ABLE TO CLEAR THE ALARM AND REWIND THE INSULIN PUMP. CUSTOMER STATED FILL CANNULA WAS RECORDED IN DAILY HISTORY. 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
    2769387 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 HG50FJ0ZZ 000000763000414344

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female