BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 15947800 · Received December 9, 2022

    Report

    Report Number
    2032227-2022-373571
    Event Type
    Malfunction
    Date Received
    December 9, 2022
    Date of Event
    November 17, 2022
    Report Date
    March 31, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000521554
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP PASSED THE SELF TEST, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST AND DAT AT 0.08735 INCHES. HOWEVER, THE PUMP HAD A HIGH SLEEP CURRENT MEASUREMENT. 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 UNEXPECTED OCCLUSIONS OR INSULIN FLOW BLOCKED ALARM NOTED DURING TESTING. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUMP. NO DELIVERY ALARM/INSULIN FLOW BLOCKED ALARM WAS FOUND IN THE FORMATTED HISTORY FILE ON THE EVENT DATE: 11/17/2022 13:43:43.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) DURING BOLUS DELIVERY. 11/17/2022 13:47:17.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) DURING BOLUS DELIVERY. 11/17/2022 13:57:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) DURING BASAL DELIVERY. 11/17/2022 14:12:25.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) DURING BOLUS DELIVERY. 11/17/2022 14:22:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) DURING BASAL DELIVERY. 11/17/2022 14:38:34.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) DURING PRIME POWER MANAGEMENT GRAPH WAS SUCCESSFULLY GENERATED. THE POWER MANAGEMENT TOOL CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WERE WITHIN SPEC RANGE. NO ALARMS/ALERTS WERE NOTED. NO POWER ERROR 25, LOW BATTERY ALERT, POWER LOSS ALARM AND REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM RECORDED IN THE FORMATTED HISTORY FILE FOR THE EVENT DATE. HOWEVER, INSERT BATTERY ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 11/16/2022 15:24:23.000. 11/17/2022 15:23:45.000. 11/17/2022 15:33:00.000. LOW BATTERY ALERT WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 11/16/2022 05:50:00.000. REPLACE BATTERY ALERT WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 11/16/2022 15:21:00.000. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND SLIGHT CORROSION ON THE PCBA 1 AND PCBA 2. NO CORROSION OR MOISTURE DAMAGE FOUND ON THE FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. THE ORIGINAL PCBA 2 WAS CLEANED, INSTALLED IN A TEST PCBA 1, CASE, INTERNAL BATTERY AND MOTOR. POWERED THE PUMP ON USING THE BATTERY SIMULATOR AND CONTINUED TESTING. THE PUMP PASSED THE SLEEP CURRENT MEASUREMENT. THE ORIGINAL PCBA 1 WAS CLEANED, INSTALLED IN A TEST PCBA 2, CASE, INTERNAL BATTERY AND MOTOR. POWERED THE PUMP ON USING THE BATTERY SIMULATOR AND CONTINUED TESTING. THE PUMP PASSED THE SLEEP CURRENT MEASUREMENT. THE ORIGINAL PCBA 1 WAS INSTALLED IN THE ORIGINAL PCBA 2, CASE, INTERNAL BATTERY AND MOTOR. POWERED THE PUMP ON USING THE BATTERY SIMULATOR AND CONTINUED TESTING. THE PUMP PASSED THE SLEEP CURRENT MEASUREMENT. THE PUMP HAD AN INTERMITTENT HIGH SLEEP CURRENT MEASUREMENT (UNEXPECTED BATTERY POWER LOSS OR REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM) DUE TO SLIGHT CORROSION ON THE PCBA 1 AND PCBA 2. PLEASE SEE BELOW FOR PUMP ERRORS/ALARMS NOTED 1 WEEK PRIOR TO THE EVENT DATE 17-NOV-2022 IN THE FORMATTED HISTORY FILE.  PUMP ERROR 53 ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 11/17/2022 11:00:09.000. AS PER GLOBAL LOGIC ANALYSIS (ESF# 3764387), PUMP ERROR 53 ALARM (LINE NUMBER 265 FILE NUMBER 32), SUSPECTED ON HW. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A SCRATCHED CASE. NO DELIVERY ALARM/INSULIN FLOW BLOCKED ALARM WAS NOT CONFIRMED. INTERMITTENT HIGH SLEEP CURRENT MEASUREMENT (UNEXPECTED BATTERY POWER LOSS OR REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM) WAS CONFIRMED DUE TO SLIGHT CORROSION ON THE PCBA 1 AND PCBA 2. PUMP ERROR 53 ALARM WAS CONFIRMED ACCORDING IN THE FORMATTED HISTORY FILE DOWNLOAD, SUSPECTED ON HW. 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.

    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. 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 INSULIN DOES NOT EXIT THE CANNULA EVEN THOUGH THE INFUSION SET IS NOT OCCLUDED. ALSO, EVEN THOUGH INSULIN DOES NOT EXIT, THE PUMP DOES NOT GIVE ANY ALARMS. TROUBLESHOOTING WAS PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER DISCONTINUED USING THE PUMP AND THE PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2842078 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 HG61FG5ZZ 000000763000521554

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown