BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 13771432 · Received March 15, 2022

    Report

    Report Number
    2032227-2022-139185
    Event Type
    Malfunction
    Date Received
    March 15, 2022
    Date of Event
    October 18, 2021
    Report Date
    April 4, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000414344
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    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

    RETAINER RING=BLACK. CUSTOMER COMPLAINED ON 10/18/2021 THE PUMP ALARMED PUMP ERROR 53 AND FAILED BATTERY TEST. PUMP PASSED DISPLACEMENT TEST, SELF TEST, ACTIVE CURRENT MEASUREMENT AND SLEEP CURRENT MEASUREMENT. PUMP SUCCESSFULLY DOWNLOADED TO THUMP. THE POWER MANAGEMENT GRAPH CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WERE WITHIN SPEC RANGE. NO FAILED BATTERY TEST NOTED DURING TESTING. VERIFIED PUMP ALARMED FAILED BATTERY TEST ON 10/18/2021 06:00:28.000 IN PUMP DOWNLOADED HISTORY. NO PUMP ERROR 53 ALARMS NOTED DURING TESTING. HOWEVER, THE FORMATTED HISTORY FILE CONFIRMED THE PUMP ALARMED PUMP ERROR 53 ALARM (LINE NUMBER 35017 FILE NUMBER 18273) ON 06/26/2021 06:44:25.000 DUE TO SOFTWARE ERROR AS PER GLOBAL LOGIC ANALYSIS ESF3470387. NO MOISTURE DAMAGE NOTED TO ELECTRONIC ASSEMBLY OR MOTOR ASSEMBLY PER VISUAL INSPECTION. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: SCRATCHED CASE, PILLOWING KEYPAD OVERLAY AND STAINED KEYPAD OVERLAY. THE P-CAP/RESERVOIR DOES LOCK PROPERLY. NO FAILED BATTERY TEST OR PUMP ERROR 53 NOTED DURING TESTING. HOWEVER, CONFIRMED PUMP ALARMED FAILED BATTERY TEST ON 10/18/2021 06:00:28.000 IN PUMP DOWNLOADED HISTORY AND CONFIRMED THE PUMP ALARMED PUMP ERROR 53 ALARM (LINE NUMBER 35017 FILE NUMBER 18273) ON 06/26/2021 06:44:25.000 DUE TO SOFTWARE ERROR. 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 FAILED BATT TEST, 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
    2268476 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 HG559NFZZ 000000763000414344

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Unknown