BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1884L MM780G BLE 3.0 MG/ML

    MDR report key: 20949850 · Received December 17, 2024

    Report

    Report Number
    2032227-2024-287876
    Event Type
    Malfunction
    Date Received
    December 17, 2024
    Date of Event
    November 24, 2024
    Report Date
    January 14, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    PMA / PMN Number
    P160017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UNABLE TO PERFORM THE DISPLACEMENT TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST, OCCLUSION TEST, SLEEP CURRENT MEASUREMENT TEST, ACTIVE CURRENT MEASUREMENT TEST AND SELF-TEST DUE TO CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND MOISTURE DAMAGE ON THE PCBA 1 / PCBA 2 / FORCE SENSOR, 40 PIN FLEXIBLE PRINTED CIRCUIT/LCD AND MOTOR. SUCCESSFULLY DOWNLOADED FIRMWARE / HISTORY FILES USING CREST AND THUS APPLICATION. PUMP ERROR 35 ALARM (BROKEN FORCE SENSOR ERROR) CONFIRMED IN HISTORY FILE OR TRACES (B)(6) 202420:48:31:000 PM DUE TO MOISTURE FORCE SENSOR. UNIT RECEIVED WITH CRACKED BATTERY TUBE THREADS, FADING SERIAL NUMBER LABEL AND CRACKED CASE NEAR BELT CLIP RAILS. THE UNIT P-CAP / TEST RESERVOIR LOCKS IN PLACE PROPERLY. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM CONFIRMED DUE TO PUMP ERROR 35 ALARM DUE TO MOISTURE DAMAGE. EXPOSED TO MOISTURE DAMAGE CONFIRMED. UNIT CONFIRMED DAMAGE AT BATTERY TUBE SIDE. 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 A BROKEN FORCE SENSOR THAT WAS DETECTED DURING SEATING OR REGULAR DELIVERY (CRITICAL PUMP ERROR 35). TROUBLESHOOTING WAS PERFORMED, AND AN INSULIN PUMP PERFORMED SAFETY CHECKS AND ERRORS AND FOUND THAT THE PUMP HAD OTHER CRITICAL PUMP ERRORS. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1884L. THE CUSTOMER REPORTED PHYSICAL DAMAGE (CRACK OR SCRATCH) ON THE PUMP NOT RELATED TO THE RETAINER RING. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WAS INSTRUCTED TO DISCONTINUE DEVICE USE AND REVERT TO THE BACKUP PLAN PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. MMT-1884L WAS REQUESTED AND THE CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266080 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 NG3536767H

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female