BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L

    MDR report key: 20630500 · Received November 7, 2024

    Report

    Report Number
    2032227-2024-265331
    Event Type
    Injury
    Date Received
    November 7, 2024
    Date of Event
    October 5, 2024
    Report Date
    March 12, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000533861
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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 0.08730 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 SS EVENT DATE OF 05-OCT-2024, THERE IS NO UNEXPECTED ALARMS/SUSPENDS. PLEASE SEE BELOW FOR THE DAILY TOTAL OF BASAL/BOLUS AND ALL INSULIN DELIVERED ON THE SS EVENT DATE OF 05-OCT-2024 LISTED ON SMARTSOLVE. DAILYTOTALCOLLECTIONSTARTTIME: 10/05/2024 00:00:00.000 DAILYTOTALOFALLINSULINDELIVERED: 213250 (21.325 U) DAILYTOTALOFBASALINSULINDELIVERED: 137250 (13.725 U) DAILYTOTALOFBOLUSINSULINDELIVERED: 76000 (7.6 U) IN FURTHER FULL REVIEW OF THE PUMP HISTORY/TRACES ON THE CUSTOMER'S EVENT DATE OF 03-OCT-2024, THERE IS NO UNEXPECTED ALARMS/SUSPENDS. PLEASE SEE BELOW FOR THE DAILY TOTAL OF BASAL/BOLUS AND ALL INSULIN DELIVERED ON THE CUSTOMER'S EVENT DATE OF 03-OCT-2024 LISTED ON SMARTSOLVE. DAILYTOTALCOLLECTIONSTARTTIME: 10/03/2024 00:00:00.000 DAILYTOTALOFALLINSULINDELIVERED: 221250 (22.125 U) DAILYTOTALOFBASALINSULINDELIVERED: 85250 (8.525 U) DAILYTOTALOFBOLUSINSULINDELIVERED: 136000 (13.6 U) THERE WAS ¿NO¿ NO DELIVERY ALARM/INSULIN FLOW BLOCKED ALARM RECORDED IN THE FORMATTED HISTORY FILE ON THE SS EVENT DATE OF 05-OCT-2024 AND CUSTOMER'S EVENT DATE OF 03-OCT-2024. HOWEVER, NO DELIVERY ALARM/INSULIN FLOW BLOCKED ALARM WAS FOUND ON: 10/01/2024 22:47:07.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) DURING BOLUS DELIVERY. 10/02/2024 11:42:05.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) DURING BOLUS DELIVERY. 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 UNEXPECTED NO DELIVERY ALARM/INSULIN FLOW BLOCKED ALARM NOTED. PLEASE SEE BELOW FOR PUMP ERROR(S)/ALARM(S) NOTED 1 WEEK PRIOR TO THE SS EVENT DATE OF 05-OCT-2024 AND CUSTOMER'S EVENT DATE OF 03-OCT-2024 IN THE FORMATTED HISTORY FILE. SENSOREXPIREDALERT (794) WAS FOUND ON: 09/30/2024 06:10:49.000 SENSORERRORALERT (801) WAS FOUND ON: 09/30/2024 20:50:03.000 TO 09/30/2024 23:50:00.000 10/01/2024 00:50:02.000 TO 10/01/2024 23:32:55.000 10/02/2024 00:07:54.000 TO 10/02/2024 22:17:58.000. LOSTSENSOR1ALERT (780) WAS FOUND ON: 10/02/2024 23:11:00.000 10/05/2024 14:30:00.000. LOSTSENSOR2ALERT (781) WAS FOUND ON: 10/02/2024 23:27:00.000 10/05/2024 14:47:00.000 10/05/2024 14:57:00.000. THE PUMP WAS PROGRAMMED WITH A TEST GUARDIAN LINK (3) TRANSMITTER AND A GLUCOSE SENSOR SIMULATOR. THE PUMP CONNECTED SUCCESSFULLY TO THE TRANSMITTER AND DISPLAYED ¿TRANSMITTER CONNECTION SUCCESSFUL¿. THE PUMP COMMUNICATED PROPERLY WITH GLUCOSE SENSOR SIMULATOR AND DISPLAYED THE CALIBRATE YOUR SENSOR ALARM PROPERLY AFTER COMPLETION OF THE WARM UP. THE PUMP CALIBRATED AND DISPLAYED THE PROGRAMMED VALUE OF 240 MG/DL PROPERLY ON THE DISPLAY GRAPH. NO SENSOR EXPIRED ALERT, SENSOR ERROR ALERT, LOST SENSOR ALERT OR UNEXPECTED SENSOR ERRORS OR ANOMALIES WERE NOTED DURING TESTING. LOW BATTERY ALERT WAS FOUND ON: 10/05/2024 17:59:00 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. UPON CHECKING ON THE POWER DATA/DETAIL TRACE FILE, LOW BATTERY ALERT WAS EXPECTED SINCE THE BATTERY IN THE PUMP IS LOW ON POWER. THE CUSTOMER HAD USED A LOW POWER BATTERY. NO UNEXPECTED LOW BATTERY ALERT NOTED DURING TESTING. THE PUMP WAS RECEIVED WITHOUT A BATTERY CAP INSTALLED. THE PUMP WAS RECEIVED WITHOUT A BATTERY INSTALLED. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A SCRATCHED CASE. THE PUMP PASSED ALL THE REQUIRED TESTING. UNABLE TO VERIFY CUSTOMER ALLEGED FOR HIGH BGS/DKA. CUSTOMER ALLEGED FOR NO DELIVERY ALARM/INSULIN FLOW BLOCKED ALARM WAS NOT CONFIRMED. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5. 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. SELECT PATIENT INFORMATION CANNOT BE PROVIDED DUE TO REGIONAL PRIVACY REGULATIONS. THE REPORTED DEVICE IS NOT MARKETED IN THE UNITED STATES, BUT IT IS A SAME/SIMILAR DEVICE TO ONE THAT IS MARKETED INSIDE THE UNITED STATES. NO CONCLUSION CAN BE DRAWN AT THIS TIME. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED HYPERGLYCEMIA, DIABETIC KETOACIDOSIS, VOMITING AND ¿INSULIN FLOW BLOCKED" ALERT. THE CUSTOMER REPORTED BLOOD GLUCOSE VALUE OF 19.6 MMOL/L. THE HIGH BLOOD GLUCOSE, VOMITING, AND DIABETIC KETOACIDOSIS WAS TREATED WITH IV INSULIN DRIP (INTRAVENOUS INSULIN INFUSION) AND EMS(EMERGENCY MEDICAL SERVICES)/AMBULANCE/ER (EMERGENCY ROOM) VISIT. THE EVENT INVOLVED PRODUCT(S) MMT-1885. TROUBLESHOOTING WAS NOT PERFORMED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. PRODUCT RETURN IS REQUIRED FOR MMT-1885.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72654 MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1885 HG6CLCDZZ 000000763000533861

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown