BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 13589568 · Received February 24, 2022

    Report

    Report Number
    2032227-2022-117673
    Event Type
    Malfunction
    Date Received
    February 24, 2022
    Date of Event
    June 8, 2021
    Report Date
    February 23, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000384289
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). ON (B)(6) 2021 THE CUSTOMER REPORTED THAT THE BATTERY LASTS LESS THAN 4 DAYS. INSERTED A TEST P-CAP INTO THE RETAINER RING, AND IT LOCKED IN PLACE PROPERLY. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: CRACKED CASE ON THE BATTERY TUBE SIDE STARTING AT THE CORNER OF THE LEFT BELT CLIP RAIL. INSULIN PUMP PASSED DISPLACEMENT, REWIND, PRIME, SEATING, BASIC OCCLUSION, FORCE SENSOR, OCCLUSION, ACTIVE CURRENT MEASUREMENT, AND SELF TESTS; IT FAILED SLEEP CURRENT MEASUREMENT TEST. THUS SOFTWARE WAS UTILIZED AND UPLOADED TRACE/HISTORY FILES PROPERLY. NO PUMP ERROR WAS NOTED DURING TESTING, IN THE PUMP HISTORY FILE, IN THE LONG TRACE FILE, OR IN THE POWER MANAGEMENT GRAPH. THE ADAPT TOOL REVEALS THAT THE FOLLOWING RELATED ALERTS, ALARMS OCCURRED IN HIGH FREQUENCY AROUND THE EVENT DATE: 104=LOW BATTERY ALERT AT (B)(6) 2021 13:39, (B)(6) 202114:19, (B)(6) 2021 22:06, (B)(6) 2021 13:50. THE ALERTS ARE WITHIN THE EXPECTED INTERVAL OF 2 WEEKS OF ONE ANOTHER. THE ADAPT TOOL DID NOT LIST ANY UNUSUAL PUMP ERRORS WHATSOEVER. THE CASE WAS CUT OPEN. AFTER VISUAL INSPECTION, DID NOT NOTE ANY SIGNS OF PREVIOUS MOISTURE PRESENCE OR CORROSION INSIDE THE BATTERY COMPARTMENT OR ON ANY OF THE BOARDS, ASSEMBLIES, AND THE MOTOR INSIDE THE INSULIN PUMP. AFTER INSERTING A KNOWN GOOD ELECTRICAL BOARD2 AND A KNOWN GOOD ELECTRICAL BOARD1 INTO THE TEST CASE, THE SLEEP CURRENT MEASUREMENT FELL WITHIN SPECS. AFTER SWAPPING THE TEST ELECTRICAL BOARD2 ONTO A KNOWN GOOD ELECTRICAL BOARD1 AND THEN INTO THE TEST CASE, THE SLEEP CURRENT MEASUREMENT READ HIGH. AFTER REPLACING THE INTERNAL BATTERY WITH A KNOWN GOOD INTERNAL BATTERY AND REPEATING THE ABOVE SAME PROCEDURE, THE SLEEP CURRENT MEASUREMENT STILL READ HIGH. FINALLY AFTER INSERTING A KNOWN GOOD ELECTRICAL BOARD2 ONTO THE TEST ELECTRICAL BOARD1 AND THEN INTO THE TEST CASE, THE SLEEP CURRENT MEASUREMENT FELL WITHIN SPECIFICATIONS AGAIN. IN SUMMARY, THE CUSTOMER¿S REPORT THAT THE BATTERY LASTS LESS THAN 4 DAYS WAS CONFIRMED DURING TESTING. THE HIGH SLEEP CURRENT MEASUREMENT IS ISOLATED TO ELECTRICAL BOARD2. 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.

    Description of Event or Problem · 0

    INFORMATION RECEIVED BY MEDTRONIC STATED THAT THE INSULIN PUMP HAD A BATTERY PROBLEM. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. TROUBLESHOOTING WAS SUCCESSFULLY PERFORMED; HOWEVER, THE CUSTOMER WILL DISCONTINUE USE OF DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2049561 MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MG/DL ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1886 HG4WV83ZZ 000000763000384289

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown