BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 15292255 · Received August 25, 2022

    Report

    Report Number
    2032227-2022-315078
    Event Type
    Malfunction
    Date Received
    August 25, 2022
    Date of Event
    April 18, 2022
    Report Date
    August 25, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000439859
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) CUSTOMER COMPLAINED ABOUT THE INSULIN PUMP HAVING A PUMP ERROR, MOTOR POWER SUPPLY VOLTAGE ERROR DETECTED. THIS IS MEASURED BEFORE EACH SINGLE PUMP STROKE, AND THEN CONTINUALLY MEASURED PERIODICALLY DURING THE ENTIRE MOTOR DRIVING PERIOD ALARM AND AN ERROR IN THE MOTOR WAS DETECTED BY READING UNEXPECTED VALUE FROM HALL SENSOR ALARM ON EVENT DATE OF APRIL 18, 2022. INSULIN PUMP PASSED SELF-TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, ACTIVE CURRENT TEST, SLEEP CURRENT TEST, DISPLACEMENT TEST. NO UNEXPECTED PUMP ERROR NOTED DURING TESTING. INSULIN PUMP SUCCESSFULLY DOWNLOADED TO THUMP. PUMP ERROR CONFIRMED IN THE PUMP HISTORY, TRACE FILES ON APRIL 18, 2022 10:24:55. PUMP ERROR WAS PRESENT IN THE HISTORY DOWNLOAD ON EVENT DATE OF APRIL 27, 20215:25:00 AND PUMP ERROR WAS ALSO PRESENT IN PUMP HISTORY ON APRIL 27, 20215:25:00. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND EVIDENCE OF MOISTURE DAMAGE ON ELECTRICAL BOARD 1. TESTED WITH A TEST P-CAP AND THE TEST P-CAP LOCKED IN PLACE PROPERLY. THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE ON THE NGP STB3 AND PASSED. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: SCRATCHED CASE, PILLOWING KEYPAD OVERLAY, CRACKED CASE, AND LABEL DAMAGE. PUMP ERROR ALARMS WERE CONFIRMED. THIS ALARM IS GENERATED WHEN THE PUMP DETECTS MOVEMENT IN HALL SENSOR COUNTS THAT ARE UNEXPECTED SINCE THE PUMP DID NOT COMMAND MOTOR MOVEMENT ALARM CONFIRMED IN THE PUMP HISTORY, TRACE FILES ON APRIL 18, 2022 10:24:55, PROBLEM ISOLATED TO THE MOTOR. 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 INSULIN PUMP RECEIVED MULTIPLE PUMP ERROR ALARM. CUSTOMER ABLE TO SUCCESSFULLY CLEAR ALARM AND WAS CUSTOMER ABLE TO COMPLETE REWIND. THE CUSTOMER PERFORMED DISPLACEMENT TEST WAS SUCCESSFULLY PASSED FOR INSULIN PUMP. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. TROUBLESHOOTING WAS PERFORMED; HOWEVER, CUSTOMER DISCONTINUED THE USE OF DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432776 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 HG59CHPZZ 000000763000439859

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Female