BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1885L MM780G BLE MMOL

    MDR report key: 21707353 · Received March 27, 2025

    Report

    Report Number
    2032227-2025-144428
    Event Type
    Malfunction
    Date Received
    March 27, 2025
    Date of Event
    March 7, 2025
    Report Date
    June 12, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PUMP WAS RECEIVED WITH A CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. UNABLE TO PERFORM 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 AND DISPLACEMENT TEST DUE TO CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. SUCCESSFULLY DOWNLOADED PUMP TRACES AND HISTORY FILE USING THUMP. IN FURTHER REVIEW OF THE FORMATTED HISTORY FILE 2 DAYS PRIOR TO THE EVENT DATE OF 07-MAR-2025, THESE PUMP ERROR(S)/ALARM(S) WERE NOTED: INSERT BATTERY ALARM WAS FOUND ON: (B)(6) 2025 15:15:25.000. (B)(6) 2025 15:39:29.000. 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. LOSTSENSOR1ALERT (780) WAS FOUND ON: (B)(6) 2025 08:34:00.000. (B)(6) 2025 15:14:00.000. UNABLE TO TEST FOR LOST SENSOR ALERT DUE TO CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. LOST SENSOR ALERT WAS UNKNOWN. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM AND PUMP ERROR 35 ALARM CONFIRMED IN THE FORMATTED HISTORY FILE ON (B)(6) 2025 15:14:01.000 AND (B)(6) 2025 15:24:00.000. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND CORROSION ON THE PCBA 1, PCBA 2 AND FORCE SENSOR. NO CORROSION OR MOISTURE DAMAGE FOUND ON THE MOTOR AND VIBRATOR ASSEMBLY NOTED. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A SCRATCHED CASE AND A CRACKED CASE-CORNER OF BELT CLIP RAILS NEAR THE BATTERY TUBE COMPARTMENT. UNABLE TO PERFORM THE REQUIRED TESTING DUE TO CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM CONFIRMED DUE TO FATAL ALARM PUMP ERROR 35. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM AND PUMP ERROR 35 ALARM CONFIRMED DUE TO CORROSION ON THE PCBA 1, PCBA 2 AND FORCE SENSOR. 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. SELECT PATIENT INFORMATION CANNOT BE PROVIDED DUE TO REGIONAL PRIVACY REGULATIONS. THE REPORTED DEVICE IS NOT MARKETED IN THE UNITED STATES, BUT IT IS A SAME/SIMILAR DEVICE TO ONE THAT IS MARKETED INSIDE THE UNITED STATES. 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 THE CUSTOMER RECEIVED PUMP ERROR 35 (A BROKEN FORCE SENSOR WAS DETECTED DURING SEATING OR REGULAR DELIVERY.). THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1885L. TROUBLESHOOTING WAS PERFORMED. EXPLAINED THE PUMP PERFORMS SAFETY CHECKS AND AN ERROR WAS FOUND. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE THE USE OF THE DEVICE AND REVERT TO THE BACKUP PLAN AS PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. MMT-1885L WAS REQUESTED AND CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1438506 PUMP MMT-1885L MM780G BLE MMOL AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1885L NG3705987H

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Unknown