BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 16893582 · Received May 9, 2023

    Report

    Report Number
    2032227-2023-204949
    Event Type
    Malfunction
    Date Received
    May 9, 2023
    Date of Event
    February 7, 2023
    Report Date
    May 9, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000414344
    PMA / PMN Number
    P160017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5. PUMP¿S HISTORY AND TRACE FILES DOWNLOADED SUCCESSFULLY USING THUMP SOFTWARE. UNIT PASSED DISPLACEMENT TEST, SELF TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST AND OCCLUSION TEST. NO PUMP ERROR 82 OR PUMP ERROR 81 ALARMS NOTED DURING TESTING. HOWEVER, PUMP ERROR 82 CONFIRMED IN THE PUMP HISTORY ON 02/07/2023 07:21:26.000 DUE TO HARDWARE ERROR AND PUMP ERROR 81 CONFIRMED IN THE PUMP HISTORY ON 02/07/2023 AT 07:21:26.000. ¿¿PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND¿NO EVIDENCE OF MOISTURE DAMAGE¿ON THE ELECTRONIC ASSEMBLY, MOTOR, OR FORCE SENSOR. THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE AND PASSED. TEST P-CAP / RESERVOIR LOCKS PROPERLY INTO PLACE. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: CRACKED KEYPAD OVERLAY, PILLOWING KEYPAD OVERLAY, BATTERY TUBE THREADS - CRACKED, CRACKED CASE-CORNER OF BELT CLIP RAILS AND FADED SERIAL NUMBER LABEL. PUMP ERROR 82 WAS CONFIRMED DUE TO HARDWARE ISSUE. PUMP ERROR 81 WAS CONFIRMED DUE TO SOFTWARE ISSUE. 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 THE HRM TASK DID NOT GRANT MOTOR POWER IN REASONABLE TIME(PUMP ERROR 82) AND THE MOTOR PROCESSOR DID NOT ACK A COMMAND FROM DELIVERY MANAGER IN REASONABLE TIME. DATA IN ALARM CAN IDENTIFY WHICH COMMAND IT WAS(PUMP ERROR 81). THE CUSTOMER WAS ABLE TO SUCCESSFULLY CLEAR ALARM. ASSIST THE CUSTOMER WITH PERFORMING A SELF TEST AND IT DID NOT PASS. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. TROUBLESHOOTING WAS PERFORMED SUCCESSFULLY HOWEVER, THE CUSTOMER WILL DISCONTINUE THE USE OF DEVICE. THE PRODUCT WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581926 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 HG5KUUNZZ 000000763000414344

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Male