BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 13767556 · Received March 15, 2022

    Report

    Report Number
    2032227-2022-138197
    Event Type
    Malfunction
    Date Received
    March 15, 2022
    Date of Event
    August 30, 2021
    Report Date
    March 14, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000414344
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    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 5.2A. RETAINER RING=BLACK. CUSTOMER COMPLAINED ON (B)(6) 2021 THE PUMP ALARMED PUMP ERROR 53. UNIT PASSED THE SELF TEST AND DISPLACEMENT TEST. NO PUMP ERROR 53 ALARMS NOTED DURING TESTING. UNIT SUCCESSFULLY DOWNLOAD TO THUMPS. HOWEVER, THE FORMATTED HISTORY FILE CONFIRMED THE PUMP ALARMED PUMP ERROR 53 ALARM (LINE NUMBER 1216 FILE NUMBER 709) ON (B)(6) 2021 12:02:31.000 DUE TO CORRUPTED HISTORY AS PER GLOBAL LOGIC ANALYSIS ((B)(4)). THE FORMATTED HISTORY FILE ALSO CONFIRMED THE PUMP ALARMED PUMP ERROR 15 ALARM (LINE NUMBER 442 FILE NUMBER 38) ON (B)(6) 2021 05:15:09.000 DUE TO CORRUPTED HISTORY AS PER GLOBAL LOGIC ANALYSIS ((B)(4)). 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 53 ALARMS NOTED DURING TESTING. HOWEVER, THE FORMATTED HISTORY FILE CONFIRMED THE PUMP ALARMED PUMP ERROR 53 ALARM (LINE NUMBER 1216 FILE NUMBER 709) ON (B)(6) 2021 12:02:31.000 DUE TO CORRUPTED HISTORY AS PER GLOBAL LOGIC ANALYSIS (B)(4). 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 53 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
    1789890 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 HG56946ZZ 000000763000414344

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Unknown