BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 16564051 · Received March 17, 2023

    Report

    Report Number
    2032227-2023-172457
    Event Type
    Malfunction
    Date Received
    March 17, 2023
    Date of Event
    February 23, 2023
    Report Date
    April 20, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000414344
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UNIT PASSED DISPLACEMENT, REWIND, PRIME/SEATING, BASIC OCCLUSION, FORCE SENSOR, OCCLUSION TESTS, AND SELF TESTS NO PUMP ERROR 130, 2, 53 AND 43 ALARMS DURING TESTING NOTED. THUS SOFTWARE WAS UTILIZED AND DOWNLOADED TRACE/HISTORY FILES PROPERLY. IN FURTHER FULL REVIEW IN THE PUMP HISTORY FOUND MULTIPLE 130 ALARM ON 02/24/2023 02:25:02., 02/24/2023 02:44:53, 02/24/2023 02:46:25, 02/24/2023 02:47:14, 02/24/2023 03:08:28, 02/24/2023 03:23:06, PUMP ERROR 43 ALARM ON 02/24/2023 03:00:26, 02/24/2023 03:07:51, 02/24/2023 03:08:37, PUMP ERROR 2 ON 02/24/2023 03:22:13, 02/24/2023 03:22:30 AND PUMP ERROR 53 ON 02/24/2023 03:22:13. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND MOISTURE DAMAGE ON THE PCBA1 DURING VISUAL INSPECTION. MOTOR PASSED MOTOR TEST. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: UNIT HAD SCRATCHED CASE, STAINED KEYPAD OVERLAY, CRACKED KEYPAD OVERLAY, CRACKED CASE (BATTERY TUBE), LABEL DAMAGE. IN CONCLUSION, NO UNEXPECTED PUMP ERROR PUMP ERROR 130, 2, 53 AND 43 ALARMS DURING TESTING. HOWEVER, PUMP ERROR 130, 2, 53 AND 43 ALARMS IN THE PUMP HISTORY CONFIRMED DUE TO MOISTURE DAMAGE PCBA1. 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

    (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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND 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.

    Description of Event or Problem · 0

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER RECEIVED THE ERROR CODES OF SOFTWARE ERROR DETECTED (PUMP ERROR 53), AN ERROR IN THE MOTOR WAS DETECTED BY READING UNEXPECTED VALUE FROM HALL SENSOR(PUMP ERROR 43 - 3 TIMES), INTERPROCESSOR COMMUNICATION ERROR(PUMP ERROR 2), AND THIS ALARM IS GENERATED WHEN THE PUMP DETECTS MOVEMENT IN HALL SENSOR COUNTS THAT ARE UNEXPECTED SINCE THE PUMP DID NOT COMMAND MOTOR MOVEMENT(PUMP ERROR 130). TROUBLESHOOTING WAS PERFORMED AND THE CUSTOMER WAS ABLE TO CLEAR THE ALARM SUCCESSFULLY. THE CUSTOMER WAS UNABLE TO COMPLETE THE REWIND. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE THE USE OF THE DEVICE AND REVERT TO THE BACKUP PLAN AS PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. THE PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558127 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 HG4XA67ZZ 000000763000414344

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male