BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L

    MDR report key: 13657899 · Received March 3, 2022

    Report

    Report Number
    2032227-2022-120261
    Event Type
    Malfunction
    Date Received
    March 3, 2022
    Date of Event
    July 29, 2021
    Report Date
    March 3, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000384272
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CUSTOMER COMPLAINED ON (B)(6) 2021 PUMP ALARMED PUMP ERROR 53. UNIT PASSED THE SELF TEST AND DISPLACEMENT TEST. NO PUMP ERROR 53 ALARMS NOTED DURING TESTING. HOWEVER, THE FORMATTED HISTORY FILE CONFIRMED THE PUMP ALARMED PUMP ERROR 53 ALARM (LINE NUMBER 1468 FILE NUMBER 26) ON (B)(6) 2021 03:18:00.000, PROBLEM ISOLATED TO THE ELECTRONIC ASSEMBLY AS PER GLOBAL LOGIC ANALYSIS ESF3926737. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: SCRATCHED CASE, PILLOWING KEYPAD OVERLAY AND CORRODED BATTERY TUBE. THE P-CAP/RESERVOIR DOES LOCK PROPERLY. NO PUMP ERROR 53 ALARMS NOTED DURING TESTING. HOWEVER, THE FORMATTED HISTORY FILE CONFIRMED THE PUMP ALARMED PUMP ERROR 53 ALARM (LINE NUMBER 1468 FILE NUMBER 26) ON (B)(6) 2021 03:18:00.000, PROBLEM ISOLATED TO THE ELECTRONIC ASSEMBLY AS PER GLOBAL LOGIC ANALYSIS ESF3926737. 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 SOFTWARE ERROR ALARM. CUSTOMER WAS ASSISTED WITH CLEARING THE ALARM. CUSTOMER WAS ABLE TO SUCCESSFULLY CLEAR THE ALARM. CUSTOMER WAS ABLE TO COMPLETE INSULIN PUMP REWIND. CUSTOMER STATED THAT THEY PERFORMED SELF TEST AND INSULIN PUMP PASSED IT. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. TROUBLESHOOTING WAS PERFORMED SUCCESSFULLY HOWEVER, THE CUSTOMER WILL DISCONTINUE THE USE OF DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709392 MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1885 000000763000384272

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown