BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L

    MDR report key: 16154935 · Received January 12, 2023

    Report

    Report Number
    2032227-2023-108787
    Event Type
    Malfunction
    Date Received
    January 12, 2023
    Date of Event
    March 11, 2022
    Report Date
    January 12, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). S/W 6.5V. RETAINER RING = BLACK. THE CUSTOMER ALLEGED POSSIBLE OVER DELIVERY ANOMALY, LOW BG'S AND UNITS LEFT IN RESERVOIR ANOMALY/EMPTY RESERVOIR ANOMALY ON 11-MAR-2022. THE PUMP PASSED THE FUNCTIONAL TEST, INCLUDING THE SELF TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST AND THE DAT AT 0.0869 INCHES. NO OVER DELIVERY ANOMALY NOTED. DURING THE OCCLUSION TEST, INSERTED A TEST P-CAP AND A WATER FILLED RESERVOIR INTO THE RESERVOIR COMPARTMENT. THE PUMP RECOGNIZED THE WATER FILLED RESERVOIR IN THE RESERVOIR COMPARTMENT. PROGRAMMED AND DELIVERED A 2.0 UNIT FILL CANNULA, THE WATER EXITED THE INFUSION SET DURING THE 2.0 UNIT FILL CANNULA DELIVERY. REMOVED AND INSPECTED THE TEST RESERVOIR. RESERVOIR IS SHOWING THE SAME AMOUNT OF INSULIN AS SHOWN ON THE PUMP'S STATUS SCREEN. THE CUSTOMER'S BASAL PROFILE WAS SET FOR 24 HR TOTAL = 6.7 UNITS. PLEASE SEE BELOW FOR THE REWINDS, FILL CANNULA AND RESERVOIR VOLUME AFTER FILL. THE 24 HOUR TOTAL WOULD NOT EMPTY OUT THE RESERVOIR. 03/08/2022 14:59:08.000 REWIND (54) 03/08/2022 15:00:19.000 CANNULATUBINGFILLDELIVERED (26) CANNULATUBINGFILLTYPE: TUBINGFILL (0) FILLAMOUNTDELIVERED: 68450 (6.845 U) RESERVOIRVOLUMEAFTERFILL: 1611750 (161.175 U) 03/08/2022 DAILYTOTALOFBOLUSINSULINDELIVERED: 279750 (27.975 U) 03/09/2022 12:39:33.000 REWIND (54) 03/09/2022 12:40:39.000 CANNULATUBINGFILLDELIVERED (26) CANNULATUBINGFILLTYPE: TUBINGFILL (0) FILLAMOUNTDELIVERED: 47693 (4.7693 U) RESERVOIRVOLUMEAFTERFILL: 1442500 (144.25 U) 03/09/2022 15:32:26.000 REWIND (54) 03/09/2022 15:33:47.000 CANNULATUBINGFILLDELIVERED (26) CANNULATUBINGFILLTYPE: CANNULAFILL (1) FILLAMOUNTDELIVERED: 6000 (0.6 U) RESERVOIRVOLUMEAFTERFILL: 1951000 (195.1 U) 03/09/2022 DAILYTOTALOFBOLUSINSULINDELIVERED: 358750 (35.875 U) 03/10/2022 07:35:59.000 REWIND (54) 03/10/2022 07:36:53.000 CANNULATUBINGFILLDELIVERED (26) CANNULATUBINGFILLTYPE: TUBINGFILL (0) FILLAMOUNTDELIVERED: 71955 (7.1955 U) RESERVOIRVOLUMEAFTERFILL: 1768250 (176.825 U) 03/10/2022 21:51:33.000 REWIND (54) 03/10/2022 21:52:25.000 CANNULATUBINGFILLDELIVERED (26) CANNULATUBINGFILLTYPE: TUBINGFILL (0) FILLAMOUNTDELIVERED: 67988 (6.7988 U) RESERVOIRVOLUMEAFTERFILL: 1922250 (192.225 U) 03/10/2022 DAILYTOTALOFBOLUSINSULINDELIVERED: 273500 (27.35 U) 03/11/2022 10:46:56.000 REWIND (54) 03/11/2022 10:48:32.000 CANNULATUBINGFILLDELIVERED (26) CANNULATUBINGFILLTYPE: TUBINGFILL (0) FILLAMOUNTDELIVERED: 61900 (6.19 U) RESERVOIRVOLUMEAFTERFILL: 1928250 (192.825 U) 03/11/2022 DAILYTOTALOFBOLUSINSULINDELIVERED: 18500 (1.85 U) THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: MINOR SCRATCHED DISPLAY WINDOW, SCRATCHED DISPLAY WINDOW COVER, SCRATCHED CASE, PILLOWING KEYPAD OVERLAY, STAINED KEYPAD OVERLAY AND CRACKED KEYPAD OVERLAY AT THE SELECT BUTTON. THE TEST P-CAP AND RESERVOIR DOES LOCK IN PLACE IN THE RESERVOIR COMPARTMENT. HISTORY DOWNLOAD WAS SUCCESSFUL USING THUMP AND CARELINK UPLOAD WAS SUCCESSFUL. THERE WAS 31 BOLUSES LISTED IN THE PUMP HISTORY FILE ON THE EVENT DATE. PLEASE SEE THE FIRST 10 BOLUSES LISTED IN THE PUMP HISTORY FILE ON THE EVENT DATE. 03/11/2022 00:05:07.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5) NORMALBOLUSAMOUNTPROGRAMMED: 250 (0.025 U) BOLUSAMOUNTDELIVERED: 250 (0.025 U) 03/11/2022 04:35:09.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5) NORMALBOLUSAMOUNTPROGRAMMED: 1000 (0.1 U) BOLUSAMOUNTDELIVERED: 1000 (0.1 U) 03/11/2022 04:40:11.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5) NORMALBOLUSAMOUNTPROGRAMMED: 1250 (0.125 U) BOLUSAMOUNTDELIVERED: 1250 (0.125 U) 03/11/2022 04:45:09.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5) NORMALBOLUSAMOUNTPROGRAMMED: 1000 (0.1 U) BOLUSAMOUNTDELIVERED: 1000 (0.1 U) 03/11/2022 04:50:09.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5) NORMALBOLUSAMOUNTPROGRAMMED: 750 (0.075 U) BOLUSAMOUNTDELIVERED: 750 (0.075 U) 03/11/2022 04:55:09.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5) NORMALBOLUSAMOUNTPROGRAMMED: 1000 (0.1 U) BOLUSAMOUNTDELIVERED: 1000 (0.1 U) 03/11/2022 05:00:09.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5) NORMALBOLUSAMOUNTPROGRAMMED: 750 (0.075 U) BOLUSAMOUNTDELIVERED: 750 (0.075 U) 03/11/2022 05:05:11.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5) NORMALBOLUSAMOUNTPROGRAMMED: 1250 (0.125 U) BOLUSAMOUNTDELIVERED: 1250 (0.125 U) 03/11/2022 05:10:09.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5) BOLUSAMOUNTDELIVERED: 1000 (0.1 U) 03/11/2022 05:15:09.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5) NORMALBOLUSAMOUNTPROGRAMMED: 1000 (0.1 U) BOLUSAMOUNTDELIVERED: 1000 (0.1 U) THE PUMP PASSED THE FUNCTIONAL TESTING. UNABLE TO CONFIRM ALLEGED LOW BG'S. POSSIBLE OVER DELIVERY ANOMALY WAS NOT CONFIRMED. UNITS LEFT IN RESERVOIR ANOMALY AND EMPTY RESERVOIR ANOMALY WERE 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 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

    MEDTRONIC RECEIVED INFORMATION THAT POSSIBLE OVER DELIVERY ANOMALY OCCURRED. THERE WAS NO ADVERSE IMPACT OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2075015 MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1885

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown