BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 13767421 · Received March 15, 2022

    Report

    Report Number
    2032227-2022-138104
    Event Type
    Malfunction
    Date Received
    March 15, 2022
    Date of Event
    December 28, 2021
    Report Date
    May 2, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000414344
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 ABOUT THE UNIT HAVING A PUMP ERROR 63 AND PUMP ERROR 53 ON EVENT DATE OF DEC 28 2021. DEVICE PASSED DISPLACEMENT TEST AND SELF TEST AND P-CAP/RESERVOIR DOES LOCK PROPERLY. HISTORY/TRACE DOWNLOADS WERE SUCCESSFUL USING THUMP SOFTWARE. PUMP TRACE DOWNLOAD CONFIRMED THE PUMP ALARMED PUMP ERROR 63 VARIABLE 12 ON 12/31/2021 00:09:03.000. PUMP ERROR 53 (FILE NUMBER = 10524, LINE NUMBER = 8192) WAS PRESENT IN THE HISTORY DOWNLOAD ON EVENT DATE OF 12/28/2021 00:15:37.000, ESF#: ESF 3764387. THE ELECTRONIC ASSEMBLIES WERE INSPECTED AND NO ANOMALIES NOTED. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: PILLOWING KEYPAD OVERLAY, KEYPAD OVERLAY TEXTURE DAMAGE AND DAMAGED DISPLAY WINDOW COVER. NO MOISTURE DAMAGE NOTED ON PCB1/PCB2 NOTED UPON VISUAL INSPECTION OF COMPONENTS. PUMP TRACE DOWNLOAD CONFIRMED THE PUMP ALARMED PUMP ERROR 63 VARIABLE 12 ON 12/31/2021 00:09:03.000 AND PUMP ERROR 53 (FILE NUMBER = 10524, LINE NUMBER = 8192) CONFIRMED DUE TO POSSIBLE HARDWARE ERROR, ESF#: ESF 3764387. PROBLEM ISOLATED TO THE STACK. 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 63, 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
    956531 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 HG5CZ6DZZ 000000763000414344

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Unknown