BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 15925035 · Received December 6, 2022

    Report

    Report Number
    2032227-2022-371334
    Event Type
    Malfunction
    Date Received
    December 6, 2022
    Date of Event
    November 13, 2022
    Report Date
    January 6, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000414344
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINER RING = BLACK. CASE TYPE = NGP. CUSTOMER RETURNED DEVICE FOR ALLEGED FAILED BATTERY TEST, DEVICE ERROR 42, AND DEVICE ERROR 37 FOUND ON NOVEMBER 13, 2022. DEVICE PASSED DISPLACEMENT TEST, REWIND TEST, PRIME/SEATING, BASIC OCCLUSION TEST, FORCE SENSOR TEST, OCCLUSION TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, AND SELF TEST. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUMP. THE POWER MANAGEMENT GRAPH CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WERE WITHIN SPEC RANGE. VERIFIED THE DEVICE ALARMED DEVICE ERROR 42 IN DEVICE DOWNLOADED HISTORY ON NOVEMBER 13, 2022 AT TIME13:58:01.000 DUE TO MOISTURE DAMAGE ON THE MOTOR FLEX CONNECTOR. VERIFIED THE DEVICE ALARMED DEVICE ERROR 37 IN DEVICE DOWNLOADED HISTORY ON NOVEMBER 13, 2022 AT TIME 15:44:37.000 DUE TO MOISTURE DAMAGE ON THE MOTOR FLEX CONNECTOR. VERIFIED THE DEVICE ALARMED FAILED BATTERY TEST ON NOVEMBER 13, 2022 AT TIME 14:19:15.000. DEVICE WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND MOISTURE DAMAGE ON THE ELECTRICAL BOARD, MOTOR, AND FORCE SENSOR. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: CRACKED KEYPAD OVERLAY, CRACKED CASE (BATTERY TUBE), CRACKED CASE-CORNER OF BELT CLIP RAILS, AND PILLOWING KEYPAD OVERLAY. DEVICE PASSED ALL TESTING, HOWEVER, DEVICE ERROR 42 AND DEVICE ERROR 37 FOUND IN DEVICE DOWNLOADED HISTORY DUE TO MOISTURE DAMAGE ON THE MOTOR. DEVICE ERROR 42 CONFIRMED. DEVICE ERROR 37 CONFIRMED. FAILED BATTERY TEST NOT CONFIRMED. 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 OBJECT ACTS 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. INITIAL REPORT WAS SUBMITTED WITH MISSING INFORMATION. THE CORRECTED INFORMATION HAS BEEN UPDATED AND PROVIDED IN SECTION B5.

    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.

    Description of Event or Problem · 0

    THE CUSTOMER HAD RECEIVED MULTIPLE PUMP ERROR ALARM. CUSTOMER WAS ABLE TO SUCCESSFULLY CLEAR ALARM. CUSTOMER UNABLE TO COMPLETE REWIND.

    Description of Event or Problem · 0

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER RECEIVED BATTERY FAILED, INSERT BATTERY, PUMP ERROR 37 AND PUMP ERROR 42 ALARMS. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. TROUBLESHOOTING WAS PERFORMED AND THE ISSUE WAS NOT RESOLVED. THE CUSTOMER WILL DISCONTINUE USING THE DEVICE AND THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292130 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 HG54M81ZZ 000000763000414344

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male