BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1880L MM770G BLE MG

    MDR report key: 21205237 · Received January 22, 2025

    Report

    Report Number
    2032227-2025-113902
    Event Type
    Malfunction
    Date Received
    January 22, 2025
    Date of Event
    January 6, 2025
    Report Date
    March 12, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000076300058619502
    PMA / PMN Number
    P160017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DURING TESTING, THE PUMP PASSED THE SLEEP CURRENT MEASUREMENT AND ACTIVE CURRENT MEASUREMENT. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: SCRATCHED CASE AND PILLOWING KEYPAD OVERLAY. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. HISTORY DOWNLOAD WAS SUCCESSFUL USING THUMP. BATTERY CYCLE 1 RECEIVED THE LOWBATTERYALERT (104) ON 01/05/2025 08:48:00 AFTER MORE THAN 7 DAYS AT 11.99 DAYS. BATTERY CYCLE 2 RECEIVED THE LOWBATTERYALERT (104) ON 12/24/2024 08:55:00 AFTER MORE THAN 7 DAYS AT 11.55 DAYS. BATTERY CYCLE 3 RECEIVED THE LOWBATTERYALERT (104) ON 12/12/2024 14:29:00 AFTER MORE THAN 7 DAYS AT 11.85 DAYS. CUSTOMER DID NOT EXPERIENCE AN UNEXPECTED POWER LOSS OF LESS THAN 7 DAYS PER THE PUMP HISTORY RECORDS. PLEASE SEE BELOW FOR THE PUMP ERROR(S)/ALARM(S) NOTED 1 WEEK PRIOR TO THE EVENT DATE 06-JAN-2025 IN THE PUMP HISTORY FILE. 01/05/2025 08:48:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: LOWBATTERYALERT (104) 01/05/2025 08:50:30.000 BATTERYREMOVED (55) 01/05/2025 08:50:30.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) 01/05/2025 08:50:45.000 BATTERYINSERTED (44) 01/06/2025 11:12:16.000 BATTERYREMOVED (55) 01/06/2025 11:12:16.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) 01/06/2025 11:12:58.000 BATTERYINSERTED (44) LOW BATTERY ALERT WAS EXPECTED DUE TO THE CUSTOMER'S BATTERY IN THE PUMP IS LOW ON POWER. THE POWER MANAGEMENT TOOL CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WAS WITHIN SPEC RANGE. LOWBATTERYALERT (104) NOT CONFIRMED. 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. DURING TESTING, THE PUMP PASSED THE SLEEP CURRENT MEASUREMENT AND ACTIVE CURRENT MEASUREMENT. CUSTOMER DID NOT EXPERIENCE AN UNEXPECTED POWER LOSS OF LESS THAN 7 DAYS PER THE PUMP HISTORY RECORDS. CHARGE/BATTERY LASTS LESS THAN EXPECTED 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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. 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 REPORTED CHARGE/BATTERY LASTS LESS THAN EXPECTED. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1880L. TROUBLESHOOTING WAS PERFORMED AND CONFIRMED CUSTOMER RECEIVED THE REPORTED ISSUE SHORT BATTERY LIFE OR A LOW BATTERY ALARM AFTER 1 WEEK OR LESS OF INSERTING NEW BATTERY. CUSTOMER IS USING MINIMED 620G/640G WITH VERSION 2.6. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. IT WAS UNKNOWN WHETHER CONTINUED USING THE DEVICE OR NOT. NO PRODUCT RETURN IS REQUIRED FOR MMT-1880L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792433 PUMP MMT-1880L MM770G BLE MG AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1880L NG3830998H 000076300058619502

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male