BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1884L MM780G BLE 3.0 MG/ML

    MDR report key: 23023687 · Received September 11, 2025

    Report

    Report Number
    2032227-2025-256485
    Event Type
    Malfunction
    Date Received
    September 11, 2025
    Date of Event
    August 15, 2025
    Report Date
    October 28, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    PMA / PMN Number
    P160017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    P-CAP LOCKED IN PLACE PROPERLY DURING TESTING. UNIT WAS SUCCESSFULLY DOWNLOADED USING (THUMP SOFTWARE). PROCEEDED WITH THE FOLLOWING TESTING TO ASSURE PROPER FUNCTIONALITY OF THE UNIT. 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). THE ADAPT TOOL WAS UTILIZED TO SEARCH FOR ALARMS THAT MAY HAVE OCCURRED IN THE PAST OR DURING COMPLAINT CALLS THAT MIGHT TRIGGER THE REASON COMPLAINT. DURING DOWNLOAD REVIEW PUMP ERROR 63 ALARM CONFIRM IN (MAIN ERROR LOG) FILE=49 LINE=2320. PUMP ERROR 63 AND PUMP ERROR 4 WERE ALSO RECORDED IN PUMP DIAGNOSTIC TRACE ON 08/15/2025 14:30:08.000, 08/15/2025 14:31:07.000, 08/15/2025 14:31:07.000, AND 08/15/2025 14:32:00.000. PER ENGINEERING TROUBLESHOOTING GUIDE, IT WAS DETERMINED THAT PUMP ERROR 63 WAS TRIGGERED BY HARDWARE ISSUE WITH THE LCD FAILURE. UNIT WAS CUT OPEN AND PERFORMED A VISUAL INSPECTION OF CONNECTORS AND ELECTRONIC ASSEMBLIES. PER VISUAL INSPECTION, IT WAS DETERMINED THAT THE INGRESS OF WATER CORRODED ELECTRONIC ASSEMBLIES, LEADING TO CRITICAL PUMP ERROR 63 AND CRITICAL PUMP ERROR (OPEN BOOK). UNIT ALSO RECEIVED WITH CRACKED CASE (BATTERY TUBE), CRACKED CASE-CORNER OF BELT CLIP RAILS, LABEL DAMAGE (FADED), CRACKED CASE, BATTERY TUBE THREADS - CRACKED, CRACKED CASE ¿ DISPLAY WINDOW CORNER, BROKEN BELT CLIP RAILS, MISSING DISPLAY WINDOW/COVER, SCRATCHED CASE, AND PILLOWING KEYPAD OVERLAY. IN CONCLUSION, CUSTOMER CONCERN WITH CRITICAL PUMP ERROR 63 AND CRITICAL PUMP ERROR (OPEN BOOK) WAS CONFIRMED. UNIT CAME IN WITH CRITICAL PUMP ERROR ALARM TRIGGERED BY PUMP ERROR 63 DUE TO MOISTURE DAMAGE ON ELECTRONIC ASSEMBLIES. IN ADDITION, CUSTOMER CONCERN WITH CRACK IN THE BATTERY TUBE SIDE OF CASE 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.

    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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. 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 RECEIVED AN OPEN BOOK IMAGE, AND THE LOCATION OF THE DAMAGE WAS ON THE CASE OF THE BATTERY TUBE SIDE. THE CUSTOMER RECEIVED PUMP ERROR 63 (HARDWARE LOW-LEVEL FAILURES). THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1884L. TROUBLESHOOTING WAS PERFORMED FOR COSMETIC DAMAGE, AND THE SERIALIZED DEVICE WILL BE REPLACED. TROUBLESHOOTING WAS PERFORMED FOR THE OPEN BOOK IMAGE, WHICH EXPLAINED THAT THE PUMP PERFORMS SAFETY CHECKS, AND AN ERROR WAS FOUND. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WAS INSTRUCTED TO DISCONTINUE DEVICE USE AND REVERT TO THE BACKUP PLAN WITH THE HEALTH CARE PROFESSIONAL'S INSTRUCTIONS. MMT-1884L WAS REQUESTED, AND THE CUSTOMER'S RESPONSE WAS THAT THE DEVICE WOULD BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2331054 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 NG3545770H

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female