BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 15903132 · Received December 2, 2022

    Report

    Report Number
    2032227-2022-369045
    Event Type
    Malfunction
    Date Received
    December 2, 2022
    Date of Event
    November 9, 2022
    Report Date
    February 27, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000545604
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    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 TEST, ACTIVE CURRENT TEST, AND SELF TEST. THE PUMP PASSED THE DISPLACEMENT ACCURACY TEST AT 0.0873 INCHES. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. NO PUMP ERROR 42, PUMP ERROR 37, PUMP ERROR 80, PUMP ERROR 4, AND PUMP ERROR 3 ALARMS WERE NOTED DURING TESTING SUCCESSFULLY DOWNLOADED PUMP HISTORY FILES AND TRACES USING THUMP SOFTWARE. PUMP ALARMED A PUMP ERROR 80 ON THE EVENT DATE OF 11/09/2022 AT 12:09:00.000 OR 12:09:00 PM DUE TO A POSSIBLE HALL SENSOR ERROR IN MOTOR APP, POSSIBLY CAUSED BY A STRONG MAGNET. PUMP ALARMED A PUMP ERROR 42 ON THE EVENT DATE OF 11/09/2022 AT 09:30:51.000 OR 9:30:51 AM. PUMP ALARMED A PUMP ERROR 37 ON THE EVENT DATE OF 11/09/2022 AT 09:30:51.000 OR 9:30:51 AM. PUMP ALARMED A PUMP ERROR 3 ON THE EVENT DATE OF 11/09/2022 AT 12:09:08.000 OR 12:09:08 PM. PUMP ALARMED A PUMP ERROR 4 ON THE EVENT DATE OF 11/09/2022 AT 12:09:08.000 OR 12:09:08 PM. 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. MOTOR WAS TESTED OUTSIDE THE PUMP AND PASSED. THE FOLLOWING WERE ALSO NOTED DURING VISUAL INSPECTION: SCRATCHED CASE, PILLOWING KEYPAD OVERLAY, AND CORRODED BATTERY TUBE. PUMP ERROR 3 AND 4 WERE CONFIRMED IN THE PUMP HISTORY FILES AND TRACES AS A CONSEQUENCE OF PUMP ERROR 80. PUMP ERROR 80 WAS CONFIRMED IN THE PUMP HISTORY FILES AND TRACES DUE TO A POSSIBLE HARDWARE ERROR, PROBLEM ISOLATED TO THE MOTOR ASSEMBLY. PUMP ERROR 42 WAS CONFIRMED IN THE PUMP HISTORY FILES AND TRACES AS A CONSEQUENCE OF PUMP ERROR 37. PUMP ERROR 37 WAS CONFIRMED IN THE PUMP HISTORY FILES AND TRACES PROBLEM ISOLATED TO THE MOTOR 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.

    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 REPORTED THAT THE INSULIN PUMP HAD MULTIPLE PUMP ERROR ALARMS. CUSTOMER WAS ABLE TO CLEAR ALARM AND WAS ABLE TO COMPLETE REWIND. CUSTOMER PERFORMED DISPLACEMENT VERIFICATION TEST AND THE TEST WAS PASSED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. TROUBLESHOOTING WAS PERFORMED; HOWEVER, THE CUSTOMER WILL DISCONTINUE USE OF THE DEVICE. THE PRODUCT WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396369 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 NG3164603H 000000763000545604

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Male