BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1884L MM780G BLE 3.0 MG/ML

    MDR report key: 20961197 · Received December 18, 2024

    Report

    Report Number
    2032227-2024-288711
    Event Type
    Malfunction
    Date Received
    December 18, 2024
    Date of Event
    November 27, 2024
    Report Date
    April 1, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    PMA / PMN Number
    P160017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UNIT PASSED SELF-TEST, REWIND, SEATING, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT ACCURACY TEST AND DISPLACEMENT TEST. UNIT SUCCESSFULLY DOWNLOADED TO THUMP AND CARELINK. THE PUMP WAS CONNECTED TO A TEST TRANSMITTER AND MONITORED WITHOUT ANY CONNECTION INTERRUPTIONS. NO ALARMS OR ALERT NOTED DURING TESTING. THE ELECTRONIC ASSEMBLIES WERE INSPECTED, AND NO ANOMALIES NOTED. HOWEVER, MOISTURE DAMAGE NOTED TO MOTOR ASSEMBLIES DURING VISUAL INSPECTION. THE P-CAP LOCKS PROPERLY INTO THE RESERVOIR COMPARTMENT. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: SCRATCHED CASE, PILLOWING KEYPAD OVERLAY, MISSING SERIAL NUMBER LABEL, MINOR SCRATCHED LCD WINDOW, CORRODED BATTERY TUBE, CORRODED MOTOR HOME SWITCH. PLEASE SEE BELOW FOR THE FIRST TEN BOLUSES LISTED ON THE EVENT DATE 27-NOV-2024 IN THE PUMP HISTORY FILE. ON (B)(6) 2024 03:31:03.000 NORMAL BOLUS DELIVERED (220), SYSTEM TIME = (B)(6) 2024 03:31:03.000, BOLUS PROGRAMMING METHOD: MANUAL BOLUS (0), BOLUS AMOUNT DELIVERED: 40000 (4 U) , ON (B)(6) 2024 12:12:53.000 NORMAL BOLUS DELIVERED (220), SYSTEM TIME = (B)(6) 2024 12:12:53.000, BOLUS PROGRAMMING METHOD: CL1GLUCOSE CORRECTION PLUS FOOD BOLUS (8), BOLUS AMOUNT DELIVERED: 169000 (16.9 U) , ON (B)(6) 2024 13:12:36.000 NORMAL BOLUS DELIVERED (220), SYSTEM TIME = (B)(6) 2024 13:12:36.000, BOLUS PROGRAMMING METHOD: CL1AUTOBOLUS (9), BOLUS AMOUNT DELIVERED: 8250 (0.825 U), ON (B)(6) 2024 13:17:36.000 NORMAL BOLUS DELIVERED (220), SYSTEMTIME = (B)(6) 2024 13:17:36.000, BOLUS PROGRAMMING METHOD: CL1AUTOBOLUS (9), BOLUS AMOUNT DELIVERED: 10000 (1 U) , ON (B)(6) 2024 13:22:39.000 NORMAL BOLUS DELIVERED (220) SYSTEMTIME = (B)(6) 2024 13:22:39.000, BOLUS PROGRAMMING METHOD: CL1MICROBOLUS (5), BOLUS AMOUNT DELIVERED: 2250 (0.225 U) , ON (B)(6) 2024 13:32:39.000 NORMAL BOLUS DELIVERED (220), SYSTEMTIME = (B)(6) 2024 13:32:39.000, BOLUS PROGRAMMING METHOD: CL1MICROBOLUS (5), BOLUS AMOUNT DELIVERED: 1750 (0.175 U) , (B)(6) 2024 13:37:44.000 NORMAL BOLUS DELIVERED (220), SYSTEMTIME = (B)(6) 2024 13:37:44.000, BOLUSPROGRAMMINGMETHOD: CL1AUTOBOLUS (9), BOLUSAMOUNTDELIVERED: 27750 (2.775 U) , ON (B)(6) 2024 13:42:33.000 NORMAL BOLUS DELIVERED (220), SYSTEMTIME = 11/27/2024 13:42:33.000, BOLUS PROGRAMMING METHOD: CL1MICRO BOLUS (5), BOLUS AMOUNT DELIVERED: 500 (0.05 U) , ON (B)(6) 2024 13:57:37.000 NORMAL BOLUS DELIVERED (220), SYSTEMTIME = (B)(6) 2024 13:57:37.000, BOLUS PROGRAMMING METHOD: CL1AUTOBOLUS (9), BOLUS AMOUNT DELIVERED: 12250 (1.225 U) , ON (B)(6) 2024 14:02:39.000 NORMAL BOLUS DELIVERED (220), SYSTEMTIME = (B)(6) 2024 14:02:39.000, BOLUS PROGRAMMING METHOD: CL1MICROBOLUS (5), BOLUS AMOUNT DELIVERED: 3000 (0.3 U). PUMP PASSED FUNCTIONAL TESTING AND NO ALARMS OR ALERTS NOTED DURING TESTING. POSSIBLE OVER DELIVERY ANOMALY AND NO COMMUNICATION TO XMTR WERE NOT CONFIRMED. MINOR SCRATCHED LCD WINDOW WAS CONFIRMED DURING ANALYSIS. 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 EXPERIENCED NO COMMUNICATION PUMP TO TRANSMITTER LOST SENSOR ALARM, DAMAGE (PHYSICAL OR COSMETIC), UNDER DELIVERY. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-7841ZN, MMT-7040A, MMT-1884L. BUMPED/DROPPED/COSMETIC DAMAGE CUSTOMER REPORTED PUMP WAS DROPPED/BUMPED AND/OR PUMP HAS POSSIBLE PHYSICAL OR COSMETIC DAMAGE. CUSTOMER REPORTED A LOSS OF COMMUNICATION BETWEEN THE TRANSMITTER AND THE PUMP. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. NO PRODUCT RETURN IS REQUIRED FOR MMT-7841ZN. NO PRODUCT RETURN IS REQUIRED FOR MMT-7040A. NO PRODUCT RETURN IS REQUIRED FOR MMT-1884L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265855 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 NG3710023H

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male