BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 16874382 · Received May 5, 2023

    Report

    Report Number
    2032227-2023-203470
    Event Type
    Malfunction
    Date Received
    May 5, 2023
    Date of Event
    April 22, 2023
    Report Date
    June 19, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000545604
    PMA / PMN Number
    P160017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. 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.

    Additional Manufacturer Narrative · 0

    THE PUMP PASSED THE DISPLACEMENT TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST, OCCLUSION TEST, SLEEP CURRENT MEASUREMENT TEST, ACTIVE CURRENT MEASUREMENT TEST, AND SELF TEST. THE PUMP PASSED THE DISPLACEMENT ACCURACY TEST AT 0.0874 INCHES. NO PUMP ERROR 3, 15, 81, AND 19 ALARMS WERE NOTED DURING TESTING. SUCCESSFULLY DOWNLOADED PUMP HISTORY FILES AND TRACES USING THUMP SOFTWARE. PUMP ALARMED A PUMP ERROR 19 ALARM ON THE EVENT DATE OF 04/22/2023 AT 04:57:27.000. PUMP ALARMED A PUMP ERROR 15 ALARM (FILE NUMBER: 32107, LINE NUMBER: 6091, ESF #: 3764387) ON THE EVENT DATE OF 04/22/2023 AT 04:57:47.000 DUE TO A POSSIBLE HARDWARE ERROR. PUMP ALARMED A PUMP ERROR 3 ON THE EVENT DATE OF 04/22/2023 AT 04:57:56.000. PUMP ALARMED A PUMP ERROR 81 (FILE NUMBER: 16, LINE NUMBER: 393, ESF #: LWD 4812707) DUE TO A POSSIBLE HARDWARE ERROR ON THE EVENT DATE OF 04/22/2023 AT 04:57:27.000. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY, MOTOR, AND FORCE SENSOR. HOWEVER, THERE IS MOISTURE DAMAGE ISOLATED TO THE BATTERY TUBE. THE FOLLOWING WERE ALSO NOTED DURING VISUAL INSPECTION: CORRODED BATTERY TUBE, CORRODED BATTERY TUBE SPRING, SCRATCHED CASE, STAINED KEYPAD OVERLAY, CRACKED CASE (BATTERY TUBE), CRACKED CASE-CORNER OF BELT CLIP RAILS, AND PILLOWING KEYPAD OVERLAY. PUMP ERROR 15 WAS CONFIRMED IN THE PUMP HISTORY FILES AND TRACES DUE TO A HARDWARE ERROR, PROBLEM ISOLATED TO THE ELECTRONIC ASSEMBLY. PUMP ERROR 81 WAS CONFIRMED IN THE PUMP HISTORY FILES AND TRACES DUE TO A HARDWARE ERROR, PROBLEM ISOLATED TO THE ELECTRONIC ASSEMBLY. PUMP ERROR 19 WAS CONFIRMED IN THE PUMP HISTORY FILES AND TRACES AS A CONSEQUENCE OF PUMP ERROR 81. PUMP ERROR 3 WAS CONFIRMED DURING TESTING AS A CONSEQUENCE OF PUMP ERROR 15. MOISTURE DAMAGE WAS CONFIRMED FOUND ISOLATED ON THE BATTERY TUBE. 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 CUSTOMER RECEIVED PUMP ERROR 3 - THE MAIN ARM CANNOT COMMUNICATE WITH THE MOTOR ARM, PUMP ERROR 15 - THE CRITICAL BLOCK AND INVERSE CRITICAL BLOCK DID NOT ADD TO ZERO, PUMP ERROR 19 - GENERATED IF MINUTE EVENT IS NOT RECEIVED FROM MOTOR PROCESSOR OR THE SW WATCHDOG TASK IS NOT RUNNING PROPERLY AND PUMP ERROR 81 - THE MOTOR PROCESSOR DID NOT ACK A COMMAND FROM DELIVERY MANAGER IN REASONABLE TIME. DATA IN ALARM CAN IDENTIFY WHICH COMMAND IT WAS. TROUBLESHOOTING WAS PERFORMED AND PUMP ERRORS WERE CLEARED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER HAD DISCONTINUE USING THE DEVICE AND WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475034 MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1880 HG6DCQ8ZZ 000000763000545604

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Male