BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1884L MM780G BLE 3.0 MG/ML

    MDR report key: 22991928 · Received September 8, 2025

    Report

    Report Number
    2032227-2025-254043
    Event Type
    Malfunction
    Date Received
    September 8, 2025
    Date of Event
    August 11, 2025
    Report Date
    October 29, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    PMA / PMN Number
    P160017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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. 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

    P-CAP LOCKED IN PLACE PROPERLY DURING TESTING. UPON BATTERY INSTALLATION, UNIT ALARMED CRITICAL PUMP ERROR (OPEN BOOK IMAGE). UNABLE TO PERFORM THE FUNCTIONAL TEST, INCLUDING THE SELF TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, AND DISPLACEMENT TEST DUE TO CRITICAL PUMP ERROR (OPEN BOOK). PROCEEDED BY CUTTING UNIT OPEN AND PERFORMING A VISUAL INSPECTION OF CONNECTORS AND ELECTRONIC ASSEMBLIES. DURING DECONSTRUCTIVE ANALYSIS, IT WAS DETERMINED THAT MOISTURE DAMAGE ON FORCE SENSOR GOLD TRACES AND CORROSION ON ELECTRONIC ASSEMBLY LEAD TO CONSTANT CRITICAL PUMP ERROR (OPEN BOOK IMAGE). THE FOLLOWING COSMETIC DAMAGES WERE NOTED: CRACKED CASE-CORNER OF BELT CLIP RAILS, CRACKED CASE (BATTERY TUBE), BATTERY TUBE THREADS - CRACKED, CRACKED CASE, CRACKED KEYPAD OVERLAY, STAINED KEYPAD OVERLAY, SCRATCHED CASE, AND PILLOWING KEYPAD OVERLAY. IN CONCLUSION CUSTOMER CONCERN OF CRITICAL PUMP ERROR ALARM (OPEN BOOK IMAGE) WAS CONFIRMED. AFTER DECONSTRUCTIVE ANALYSIS, IT WAS DETERMINED THAT CRITICAL PUMP ERROR ALARM (OPEN BOOK IMAGE) WAS CAUSED BY MOISTURE DAMAGE ON ELECTRONIC ASSEMBLY AND FORCE SENSOR GOLD TRACES. IN ADDITION, CUSTOMER CONCERN WITH CRACK IN BATTERY TUBE SIDE WAS CONFIRMED WHEN CRACKED CASE (BATTERY TUBE) AND BATTERY TUBE THREADS - CRACKED WERE NOTED. 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 TO THE PUMP, CRITICAL PUMP ERROR DUE TO MOISTURE. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1884L. TROUBLESHOOTING WAS PERFORMED AND FOUND THE DAMAGE ON BATTERY TUBE SIDE. DAMAGE WAS NOT AFFECTING THE PUMP FUNCTIONALITY. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. MMT-1884L WAS REQUESTED AND CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED. THE CUSTOMER WILL DISCONTINUE USING THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2418182 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 NG3401641H

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male