BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-1884L MM780G BLE 3.0 MG/ML

    MDR report key: 21319626 · Received February 6, 2025

    Report

    Report Number
    2032227-2025-121742
    Event Type
    Injury
    Date Received
    February 6, 2025
    Date of Event
    January 13, 2025
    Report Date
    March 10, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000819385
    PMA / PMN Number
    P160017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP POWERED UP PROPERLY AFTER BATTERY INSTALLATION. 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 0.08720 INCHES. THE PUMP WAS MONITORED FOR SEVERAL DAYS, NO BLANK DISPLAY, PUMP ERROR 23 ALARM AND UNEXPECTED BATTERY POWER LOSS NOTED. 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 TO (B)(6)2025. THERE WAS NO DATA AVAILABLE TO VERIFY UNEXPECTED ALARM(S)/SUSPENDS AND BOLUS/BASAL DELIVERY FOR THE EVENT DATES OF 27-JAN-2025, 31-MAY-2024 AND 13-JAN-2024. THERE WAS NO DATA AVAILABLE TO VERIFY UNEXPECTED PUMP ERROR(S)/ALARM(S) 1 WEEK PRIOR TO THE EVENT DATES OF 27-JAN-2025, 31-MAY-2024 AND 13-JAN-2024 IN THE FORMATTED HISTORY FILE. THERE WAS NO DATA AVAILABLE TO VERIFY IF THE CUSTOMER EXPERIENCED AN UNEXPECTED POWER LOSS OF LESS THAN 7 DAYS PER THE PUMP HISTORY RECORDS ON THE EVENT DATE OF 13-JAN-2024. IN FURTHER FULL REVIEW OF THE PUMP HISTORY/TRACES ON THE (PRIMARY) EVENT DATE OF 13-JAN-2025 AND EVENT DATES OF 26-DEC-2024 AND 11-JAN-2025, THERE WERE NO UNEXPECTED ALARMS/SUSPENDS. UNABLE TO VERIFY DAILY TOTAL OF BASAL/BOLUS AND ALL INSULIN DELIVERED ON THE (PRIMARY) EVENT DATE 13-JAN-2025 AND EVENT DATES OF 26-DEC-2024 AND 11-JAN-2025 LISTED ON SMARTSOLVE DUE TO INSUFFICIENT DATA IN THE TRACE/HISTORY FILES. 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. THERE WERE NO UNEXPECTED PUMP ERROR(S)/ALARM(S) NOTED 1 WEEK PRIOR TO THE EVENT DATE OF 26-DEC-2024 IN THE FORMATTED HISTORY FILE. PLEASE SEE BELOW FOR PUMP ERROR(S)/ALARM(S) NOTED 1 WEEK PRIOR TO THE (PRIMARY) EVENT DATE OF 13-JAN-2025 AND EVENT DATE OF 11-JAN-2025 IN THE FORMATTED HISTORY FILE. LOW BATTERY ALERT WAS FOUND ON: (B)(6)2025 03:30:00.000 (B)(6)2025 14:04:00.000 INSERT BATTERY ALARM WAS FOUND ON: (B)(6)2025 09:33:15.000 (B)(6)2025 14:04:53.000 PUMP ERROR 23 ALARM WAS FOUND ON: (B)(6)2025 14:15:04.000 POWER LOSS ALARM WAS FOUND ON: (B)(6)2025 14:15:19.000 (B)(6)2025 14:15:27.000 FAILED BATTERY ALERT/BATTERY FAILED ALARM WAS FOUND ON: (B)(6)2025 14:03:47.000 (B)(6)2025 14:13:00.000 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. UPON CHECKING ON THE POWER DATA/DETAIL TRACE FILE, FAILED BATTERY ALERT/BATTERY FAILED ALARM AND LOW BATTERY ALERT WERE EXPECTED SINCE THE BATTERY IN THE PUMP IS LOW ON POWER OR DOES NOT HAVE ENOUGH POWER. THE CUSTOMER HAD USED A LOW/NO POWER BATTERY. 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 FAILED BATTERY ALERT/BATTERY FAILED ALARM, LOW BATTERY ALERT, PUMP ERROR 23 ALARM AND POWER LOSS ALARM NOTED DURING TESTING. 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¿. NO PUMP/TRANSMITTER COMMUNICATION ANOMALY NOTED. 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 239 MG/DL PROPERLY ON THE DISPLAY GRAPH. NO UNEXPECTED SENSOR ERRORS OR ANOMALIES WERE NOTED DURING TESTING. THE PUMP PROPERLY PAIRED WITH TEST ACCU-CHEK GUIDE LINK BG METER. THE PUMP COMMUNICATED PROPERLY AND RECORDED THE 104 MG/DL TEST VALUE PROPERLY FROM TEST ACCU-CHEK GUIDE LINK BG METER. NO PUMP/BG METER COMMUNICATION ANOMALY NOTED. THE PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND IT WAS VERIFIED THAT THE BATTERY TUBE POWER CONNECTOR IS PROPERLY CONNECTED TO J7/PCB1. NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON THE PCBA 1, PCBA 2, FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. FORCE SENSOR ZERO OFFSET WITHIN SPECIFICATION (22.02 MV). THE PUMP WAS RECEIVED WITH THE ORIGINAL BATTERY CAP WITH A BROKEN 1 HEAT STAKE POST. 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 CRACKED BATTERY TUBE THREADS AND A SCRATCHED CASE. THE PUMP PASSED ALL THE REQUIRED TESTING. UNABLE TO VERIFY CUSTOMER ALLEGED FOR SENSOR GLUCOSE AND BLOOD GLUCOSE (SG/BG) ANOMALY AND LOW BGS/HIGH BGS/DKA. CUSTOMER ALLEGED FOR PUMP/TRANSMITTER COMMUNICATION ANOMALY, BLANK DISPLAY, PUMP ERROR 23 ALARM AND UNEXPECTED BATTERY POWER LOSS WERE 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

    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. 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 AND DIABETIC KETOACIDOSIS AND ALSO THE INSULIN PUMP WAS NOT WORKING. THE CUSTOMER REPORTED BLOOD GLUCOSE VALUE OF 330 MG/DL. THE CUSTOMER REPORTED HYPERGLYCEMIA AND ELEVATED KETONES/DIABETIC KETOACIDOSIS WERE TREATED WITH HOSPITALIZATION: OVERNIGHT STAY, IV INSULIN DRIP (INTRAVENOUS INSULIN INFUSION) AND THE CUSTOMER EXPERIENCED SYMPTOMS VOMITING AND CHEST TIGHTNESS. THE EVENT INVOLVED PRODUCT(S) MMT-7040A, MMT-1884L, MMT-399A, MMT-332A. TROUBLESHOOTING WAS PERFORMED FOR HIGH BLOOD GLUCOSE EVENT UNTIL THE CUSTOMER DECLINED FURTHER TROUBLESHOOTING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE CUSTOMER WILL CONTINUE USE OF THE DEVICE. NO PRODUCT RETURN IS REQUIRED FOR MMT-7040A. MMT-1884L WAS REQUESTED AND CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED. NO PRODUCT RETURN IS REQUIRED FOR MMT-399A. NO PRODUCT RETURN IS REQUIRED FOR MMT-332A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632033 PUMP MMT-1884L MM780G BLE 3.0 MG/ML AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1884L NG3675017H 000000763000819385

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Hospitalization| O| R FRN-MMT-332A-RSVR,UNOMED INF SET,OZP-MMT-7040-SNSR.