BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 13763212 · Received March 14, 2022

    Report

    Report Number
    2032227-2022-136364
    Event Type
    Malfunction
    Date Received
    March 14, 2022
    Date of Event
    January 10, 2022
    Report Date
    September 8, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000384289
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS PART OF A RETROSPECTIVE REVIEW AND REMEDIATION EFFORTS IN RESPONSE TO A WARNING LETTER. (B)(4). CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Additional Manufacturer Narrative · 0

    THE PUMP PASSED THE DISPLACEMENT TEST, ACTIVE CURRENT TEST AND SLEEP CURRENT TEST AND SELF TEST. UNIT WAS MONITORED AND NO BLANK DISPLAY NOTED DURING TESTING. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. UCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUMP. PUMP WAS MONITORED AND NO BLANK DISPLAY WAS NOTED. THE POWER MANAGEMENT GRAPH CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WERE WITHIN SPEC RANGE. NO PUMP ERROR 23 NOTED DURING TESTING, HOWEVER, AN EXPECTED PUMP ERROR 23 WAS PRESENT IN HISTORY/TRACE FILES ON (B)(6) 2022 21:56:10.000. NO PUMP ERROR 15 NOTED DURING TESTING, HOWEVER, A PUMP ERROR 15 WAS PRESENT IN HISTORY/TRACE FILES ON (B)(6) 2022 21:56:08.000 DUE TO HARDWARE ISSUES. PUMP ERROR 4 (LINENUMBER= 2690, FILENUMBER= 32122) ESF: (B)(6) CONFIRMED IN HISTORY/TRACE FILES ON (B)(6) 2022 21:56:08.000 CONFIRMED IN CONSEQUENCE OF PUMP ERROR 15. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY, MOTOR, OR FORCE SENSOR. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: PILLOWING KEYPAD OVERLAY, CRACKED KEYPAD OVERLAY, KEYPAD OVERLAY TEXTURE DAMAGE, SCRATCHED CASE AND DAMAGED DISPLAY WINDOW COVER. IN SUMMARY, CUSTOMER ALLEGATIONS FOR BLANK DISPLAY NOT CONFIRMED. AN EXPECTED PUMP ERROR 23 WAS NOTED IN HISTORY/TRACE FILES. PUMP ERROR 15 CONFIRMED IN HISTORY/TRACE FILES, PROBLEM ISOLATED TO ELECTRONIC STACK. PUMP ERROR 4 CONFIRMED IN CONSEQUENCE OF PUMP ERROR 15. 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 PUMP ERROR 15, PUMP ERROR 23, BLANK DISPLAY, PUMP ERROR 4 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
    415403 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 HG524NTZZ 000000763000384289

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown