BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L

    MDR report key: 21111732 · Received January 9, 2025

    Report

    Report Number
    2032227-2025-105873
    Event Type
    Injury
    Date Received
    January 9, 2025
    Date of Event
    November 3, 2024
    Report Date
    January 9, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000533861
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    2032227-060322-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    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. ON (B)(4), SVN#: (B)(4) - CUSTOMER RETURNED PUMP FOR ALLEGED BATTERY CAP BROKEN/CRACKED/DAMAGED FOUND ON (B)(6)2023. ON (B)(4), SVN#: (B)(4) - CUSTOMER RETURNED PUMP FOR ALLEGED HIGH BGS FOUND ON (B)(6)2022. THE PUMP WAS RECEIVED WITH A CRACKED BATTERY TUBE THREADS. 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 0.08765 INCHES. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUMP. SUCCESSFULLY UPLOADED PUMP TO CARELINK. PLEASE SEE BELOW FOR THE DATE RANGE LISTED IN THE FORMATTED HISTORY FILE. THE FORMATTED HISTORY FILE LISTS DATA FROM (B)(6)2024. THERE WAS NO DATA AVAILABLE TO VERIFY UNEXPECTED ALARM(S)/SUSPENDS AND BOLUS/BASAL DELIVERY FOR THE EVENT DATES OF 09-APR-2023 AND 10-JUL-2022. THERE WAS NO DATA AVAILABLE TO VERIFY UNEXPECTED PUMP ERROR(S)/ALARM(S) 1 WEEK PRIOR TO THE EVENT DATES OF 09-APR-2023 AND 10-JUL-2022 IN THE FORMATTED HISTORY FILE. IN FURTHER FULL REVIEW OF THE PUMP HISTORY/TRACES ON THE (PRIMARY) EVENT DATE OF 03-NOV-2024, THERE IS NO UNEXPECTED ALARMS/SUSPENDS. PLEASE SEE BELOW FOR THE DAILY TOTAL OF BASAL/BOLUS AND ALL INSULIN DELIVERED ON THE (PRIMARY) EVENT DATE OF 03-NOV-2024 LISTED ON SMARTSOLVE. DAILYTOTALCOLLECTIONSTARTTIME: 11/03/2024 00:00:00.000 DAILYTOTALOFALLINSULINDELIVERED: 1364000 (136.4 U) DAILYTOTALOFBASALINSULINDELIVERED: 281250 (28.125 U) DAILYTOTALOFBOLUSINSULINDELIVERED: 1082750 (108.275 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. PLEASE SEE BELOW FOR PUMP ERROR(S)/ALARM(S) NOTED 1 WEEK PRIOR TO THE (PRIMARY) EVENT DATE 03-NOV-2024 IN THE FORMATTED HISTORY FILE. NO DELIVERY ALARM/INSULIN FLOW BLOCKED ALARM WAS FOUND ON: (B)(6)2024 06:01:27.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) DURING BOLUS DELIVERY. (B)(6)2024 06:03:31.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) DURING BOLUS DELIVERY. (B)(6)2024 18:43:31.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) DURING BOLUS DELIVERY. (B)(6)2024 18:44:04.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) DURING BOLUS DELIVERY. NO UNEXPECTED NO DELIVERY ALARM/INSULIN FLOW BLOCKED ALARM NOTED. SENSORERRORALERT (801) WAS FOUND ON: (B)(6)2024 21:36:53.000 (B)(6)2024 22:11:53.000 (B)(6)2024 22:41:54.000 LOSTSENSOR1ALERT (780) WAS FOUND ON: (B)(6)2024 06:00:00.000 (B)(6)2024 07:20:00.000 LOSTSENSOR2ALERT (781) WAS FOUND ON: (B)(6)2024 06:16:00.000 (B)(6)2024 07:42:00.000 (B)(6)2024 07:52:00.000 SENSOREXPIREDALERT (794) WAS FOUND ON: (B)(6)2024 00:28:22.000 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 WARMUP. THE PUMP CALIBRATED AND DISPLAYED THE PROGRAMMED VALUE OF 240 MG/DL PROPERLY ON THE DISPLAY GRAPH. NO SENSOR ERROR ALERT, LOST SENSOR ALERT, SENSOR EXPIRED ALERT OR UNEXPECTED SENSOR ERRORS OR ANOMALIES WERE NOTED DURING TESTING. LOW BATTERY ALERT WAS FOUND ON: (B)(6)2024 18:59:00.000 POWER LOSS ALARM WAS FOUND ON: (B)(6)2024 21:04:18.000 (B)(6)2024 21:04:26.000 INSERT BATTERY ALARM WAS FOUND ON: (B)(6)2024 20:53:34.000 (B)(6)2024 21:03:00.000 PUMP ERROR 23 ALARM WAS FOUND ON: (B)(6)2024 21:04:03.000 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. INSERT BATTERY ALARM WAS EXPECTED SINCE THE BATTERY WAS REMOVED FROM THE PUMP. EARLIEST POWER DATA AVAILABLE PER THE POWER MANAGEMENT TOOL/DETAIL TRACE FILE IS ON 11-NOV-2024 AT 7:34:57 PM. THERE WAS NO POWER DATA AVAILABLE FOR THE EVENT DATE OF 03-NOV-2024. UNABLE TO CHECK POWER DATA FOR LOW BATTERY ALERT. PUMP ERROR 23 ALARM AND POWER LOSS ALARM WERE EXPECTED SINCE THE PUMP RESETS AFTER THE BATTERY WAS REMOVED FOR MORE THAN 10 MINUTES. NO UNEXPECTED LOW BATTERY ALERT, PUMP ERROR 23 ALARM AND POWER LOSS ALARM NOTED DURING TESTING. UNABLE TO CONFIRM BATTERY CAP BROKEN/CRACKED/DAMAGED DUE TO PUMP RECEIVED WITHOUT THE ORIGINAL BATTERY CAP. 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 AND A SERIAL NUMBER LABEL FADING. UNABLE TO CONFIRM BATTERY CAP BROKEN/CRACKED/DAMAGED DUE TO PUMP RECEIVED WITHOUT THE ORIGINAL BATTERY CAP. BATTERY CAP BROKEN/CRACKED/DAMAGED WAS UNKNOWN. COSMETIC DAMAGE WAS CONFIRMED AT THE TOP OF THE BATTERY COMPARTMENT OF THE PUMP DURING ANALYSIS. THE PUMP PASSED ALL THE REQUIRED TESTING. UNABLE TO VERIFY CUSTOMER ALLEGED FOR HIGH BGS/DKA. 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. 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 DAMAGE (PHYSICAL OR COSMETIC). THE CUSTOMER REPORTED BLOOD GLUCOSE VALUE OF 30 MMOL/L. THE CUSTOMER REPORTED HYPERGLYCEMIA, MALAISE, VOMITING, DEHYDRATED, ELEVATED KETONES/DIABETIC KETOACIDOSIS, ELEVATED KETONES/DIABETIC KETOACIDOSIS TREATED WITH HOSPITALIZATION: OVERNIGHT STAY, HOSPITALIZATION: OVERNIGHT STAY, HOSPITALIZATION: OVERNIGHT STAY, HOSPITALIZATION: OVERNIGHT STAY, HOSPITALIZATION: OVERNIGHT STAY, IV INSULIN DRIP (INTRAVENOUS INSULIN INFUSION). TROUBLESHOOTING WAS PERFORMED. THE EVENT INVOLVED PRODUCT(S) MMT-1885. CUSTOMER REPORTED PHYSICAL DAMAGE (CRACK OR SCRATCH) ON THE PUMP NOT RELATED TO THE RETAINER RING. CUSTOMER REPORTED HIGH BGS. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. MMT-1885 WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367351 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 000000763000533861

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Unknown