BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 14164941 · Received April 21, 2022

    Report

    Report Number
    2032227-2022-181588
    Event Type
    Malfunction
    Date Received
    April 21, 2022
    Date of Event
    November 8, 2021
    Report Date
    April 20, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000414344
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). RETAINER RING=BLACK. PATIENT RETURNED PRODUCT WITH ALLEGATION OF PUMP ERROR 4 ALARM ON (B)(6) 2021. UNIT POWER UP PROPERLY AFTER BATTERY INSTALLATION. UNIT WAS DOWNLOADED SUCCESSFULLY USING (THUMP SOFTWARE) FOR REFERENCE. THE ADAPT TOOL WAS UTILIZED TO SEARCH FOR ANY ALARMS THAT MAY HAVE OCCURRED IN THE PAST OR AROUND THE COMPLAINT DATE THAT MIGHT OF TRIGGER THE REASON COMPLAIN. PROCEED IT WITH THE FOLLOWING TESTING TO ASSURE PROPER FUNCTIONALITY OF THE UNIT. PUMP PASSED SELF TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST AND DISPLACEMENT TEST. THE ADAPT TOOL REVEALS THAT ON (B)(6) 2021 PUMP ERROR 3 WAS RECORDED AT 04:09, 08:54, 15:19, 17:49 HOUR. PER R&D INVESTIGATION PUMP ERROR 3 DUE TO IPC PROBLEM ERRORS. FILE NUMBER: 2002 LINE NUMBER: 1541. THE ADAPT TOOL ALSO RECORDED PUMP ERROR 4 ON (B)(6) 2021 AT 04:09, 08:54, 15:19, 17:49 HOUR. PER R&D INVESTIGATION PUMP ERROR 4 WAS THE CONSEQUENCE OF PUMP ERROR 3. PROBLEM ISOLATED TO ELECTRONIC ASSEMBLY. PROCEED IT BY CUTTING UNIT OPEN AND PERFORM A VISUAL INSPECTION ON CONNECTORS AND ELECTRONIC ASSEMBLY. ALL CONNECTORS WERE PLUGGED IN PROPERLY INCLUDING MOTOR CONNECTORS AND NO MOISTURE DAMAGE ON ELECTRONIC ASSEMBLIES WAS NOTED. UNIT RECEIVED WITH MISSING DISPLAY WINDOW COVER. IN CONCLUSION, CUSTOMER ALLEGATIONS ARE NOT CONFIRM. UNIT POWERED UP PROPERLY AFTER BATTERY INSTALLATION AND WAS TESTED SUCCESSFULLY. HOWEVER, DURING DOWNLOAD REVIEW PUMP ERROR 4 AND 3 WERE RECORDED. ALARMS WERE RECORDED DUE TO AN IPC PROBLEM ERROR. PROBLEM ISOLATED TO ELECTRONIC ASSEMBLY. 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. THE CUSTOMER WILL DISCONTINUE TO USE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1720530 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 HG58GYPZZ 000000763000414344

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male