BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 13896701 · Received March 24, 2022

    Report

    Report Number
    2032227-2022-171799
    Event Type
    Malfunction
    Date Received
    March 24, 2022
    Date of Event
    August 3, 2021
    Report Date
    March 24, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000384289
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    "THIS REPORT IS PART OF A RETROSPECTIVE REVIEW AND REMEDIATION EFFORTS IN RESPONSE TO A WARNING LETTER. (B)(4). S/W VERSION 6.5W. RETAINER RING = BLACK. CONFIRMED THE PUMP ALARMED PUMP ERROR 4, PUMP ERROR 15 AND PUMP ERROR 23. UNIT 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 4, PUMP ERROR 15 OR PUMP ERROR 23 NOTED DURING TEST. UNIT SUCCESSFULLY DOWNLOADED TO THUS. THE POWER MANAGEMENT GRAPH CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WERE WITHIN SPEC RANGE. NO POWER ANOMALIES NOTED DURING TESTING OR IN THE PUMP TRACE DOWNLOAD. VERIFIED THE PUMP ALARMED NORMAL PUMP ERROR 23 ON (B)(6) 2021 19:42:10.000 IN PUMP DOWNLOADED HISTORY. THE FORMATTED HISTORY FILE CONFIRMED THE PUMP ALARMED PUMP ERROR 4 ON (B)(6) 2021 19:42:08.000 AND PUMP ERROR 15 ALARM (LINE NUMBER 1938, FILE NUMBER 0) ON (B)(6) 2021 19:42:08.000 DUE TO SOFTWARE ERROR AS PER GLOBAL LOGIC ANALYSIS (ESF3764385). NO MOISTURE DAMAGE NOTED TO ELECTRONIC ASSEMBLY OR MOTOR ASSEMBLY PER VISUAL INSPECTION. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: SCRATCHED CASE AND PILLOWING KEYPAD OVERLAY. THE P-CAP/RESERVOIR DOES LOCK PROPERLY. NO PUMP ERROR 4, PUMP ERROR 15 OR PUMP ERROR 23 NOTED DURING TEST. NO POWER ANOMALIES NOTED DURING TESTING OR IN THE PUMP TRACE DOWNLOAD. CONFIRMED THE PUMP ALARMED A NORMAL PUMP ERROR 23 ON (B)(6) 2021 19:42:10.000 IN PUMP DOWNLOADED HISTORY. CONFIRMED PUMP ALARMED PUMP ERROR 4 ON (B)(6) 2021 19:42:08.000 AND PUMP ERROR 15 ALARM (LINE NUMBER 1938, FILE NUMBER 0) ON (B)(6) 2021 19:42:08.000 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 MULTIPLE PUMP ERROR ALARM. CUSTOMER REPORTED THEY WERE ABLE TO CLEAR THE ALARM. CUSTOMER STATED THEY WERE ABLE TO REWIND THE INSULIN PUMP. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. TROUBLESHOOTING WAS PERFORMED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2440568 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