BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L

    MDR report key: 15994312 · Received December 16, 2022

    Report

    Report Number
    2032227-2022-380328
    Event Type
    Malfunction
    Date Received
    December 16, 2022
    Date of Event
    August 9, 2022
    Report Date
    February 17, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000384272
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE NGP 780G INSULIN PUMP WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE NGP INSULIN PUMP, WHICH IS MARKETED IN THE UNITED STATES.

    Additional Manufacturer Narrative · 0

    THE PUMP PASSED THE FUNCTIONAL TESTS, 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 DAT AT 0.08710 INCHES. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUMP. SUCCESSFULLY UPLOADED PUMP TO CARELINK. IN FURTHER FULL REVIEW OF THE PUMP HISTORY/TRACES ON THE EVENT DATE OF 09-AUG-2022, THERE WAS NO UNEXPECTED ALARMS/SUSPENDS AND FOUND BOLUS DELIVERY OF DAILYTOTALOFBOLUSINSULINDELIVERED: (33 U). 08/09/2022 00:05:19.000 NORMALBOLUSDELIVERED (220), NORMALBOLUSAMOUNTPROGRAMMED: 17000 (1.7 U), BOLUSAMOUNTDELIVERED: 17000 (1.7 U). 08/09/2022 01:02:33.000 NORMALBOLUSDELIVERED (220), NORMALBOLUSAMOUNTPROGRAMMED: 9000 (0.9 U), BOLUSAMOUNTDELIVERED: 9000 (0.9 U). 08/09/2022 04:48:03.000 NORMALBOLUSDELIVERED (220), NORMALBOLUSAMOUNTPROGRAMMED: 20000 (2 U), BOLUSAMOUNTDELIVERED: 20000 (2 U). 08/09/2022 10:21:57.000 NORMALBOLUSDELIVERED (220), NORMALBOLUSAMOUNTPROGRAMMED: 34000 (3.4 U), BOLUSAMOUNTDELIVERED: 34000 (3.4 U). 08/09/2022 12:30:37.000 NORMALBOLUSDELIVERED (220), NORMALBOLUSAMOUNTPROGRAMMED: 33000 (3.3 U), BOLUSAMOUNTDELIVERED: 33000 (3.3 U). 08/09/2022 12:47:31.000 NORMALBOLUSDELIVERED (220), NORMALBOLUSAMOUNTPROGRAMMED: 4000 (0.4 U), BOLUSAMOUNTDELIVERED: 4000 (0.4 U). 08/09/2022 13:09:15.000 NORMALBOLUSDELIVERED (220), NORMALBOLUSAMOUNTPROGRAMMED: 10000 (1 U), BOLUSAMOUNTDELIVERED: 10000 (1 U). 08/09/2022 15:23:02.000 NORMALBOLUSDELIVERED (220), NORMALBOLUSAMOUNTPROGRAMMED: 34000 (3.4 U), BOLUSAMOUNTDELIVERED: 34000 (3.4 U). 08/09/2022 17:20:49.000 NORMALBOLUSDELIVERED (220), NORMALBOLUSAMOUNTPROGRAMMED: 30000 (3 U), BOLUSAMOUNTDELIVERED: 30000 (3 U). 08/09/2022 18:13:33.000 NORMALBOLUSDELIVERED (220), NORMALBOLUSAMOUNTPROGRAMMED: 10000 (1 U), BOLUSAMOUNTDELIVERED: 10000 (1 U). 08/09/2022 19:02:37.000 NORMALBOLUSDELIVERED (220), NORMALBOLUSAMOUNTPROGRAMMED: 109000 (10.9 U), BOLUSAMOUNTDELIVERED: 109000 (10.9 U). 08/09/2022 21:28:00.000 NORMALBOLUSDELIVERED (220), NORMALBOLUSAMOUNTPROGRAMMED: 20000 (2 U), BOLUSAMOUNTDELIVERED: 20000 (2 U). THE PUMP WAS PROGRAMMED WITH MULTIPLE BOLUS DELIVERIES AND ALL BOLUS DELIVERED PROPERLY THEIR INDICATED AMOUNTS (AT QUICK BOLUS SPEED) AND WERE PROPERLY RECORDED IN THE DAILY HISTORY. NO BOLUS DELIVERY ANOMALY OR HISTORY ANOMALY NOTED. NO UNDER DELIVERY ANOMALY OR OVER DELIVERY ANOMALY NOTED DURING TESTING. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON THE PCBA1, PCBA2, FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. FORCE SENSOR ZERO OFFSET WITHIN SPECIFICATION (24.3 MV). THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE ON THE NGP STB3 AND PASSED. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A MINOR SCRATCHED LCD WINDOW, A CRACKED KEYPAD OVERLAY, A PILLOWING KEYPAD OVERLAY, A SCRATCHED CASE, A CRACKED CASE-CORNER OF BELT CLIP RAILS NEAR THE BATTERY TUBE COMPARTMENT AND A END CAP ADDRESS LABEL MISSING. THE PUMP PASSED ALL THE REQUIRED TESTING. UNABLE TO VERIFY CUSTOMER ALLEGED FOR HIGH BGS AND DKA. THE FORCE SENSOR IS WITHIN SPECIFICATION AND THE MOTOR FUNCTIONING PROPERLY. CUSTOMER ALLEGED FOR POSSIBLE UNDER DELIVERY WAS 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

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER REPORTED THAT THE PUMP WAS UNDER-DELIVERING. THE CUSTOMER REPORTED DIABETIC KETOACIDOSIS AND WAS ADMITTED TO THE HOSPITAL. IT WAS UNKNOWN HOW THE PATIENT WAS TREATED IN THE HOSPITAL. THE CUSTOMER WAS UNSURE OF THE SYMPTOMS. TROUBLESHOOTING WAS PERFORMED AND FOUND THAT THE CUSTOMER WAS UNSURE ABOUT USING THE AUTO MODE FEATURE AND THE CUSTOMER WAS UNSURE WHETHER THE PUMP WAS USED WITHIN 48 HOURS PRIOR TO THE EVENT. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE USING THE PUMP AND THE PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1438779 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 HG5C3BJZZ 000000763000384272

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown