BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-1884L MM780G BLE 3.0 MG/ML

    MDR report key: 21948340 · Received May 2, 2025

    Report

    Report Number
    2032227-2025-165232
    Event Type
    Injury
    Date Received
    May 2, 2025
    Date of Event
    April 3, 2025
    Report Date
    July 27, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    PMA / PMN Number
    P160017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP PASSED ALL FUNCTIONAL TESTING INCLUDING THE SELF TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST, AND THE DAT TEST AT .08730 INCHES. THE INSULIN FLOW BLOCKED ALARM FUNCTIONED PROPERLY DURING THE BASIC OCCLUSION, OCCLUSION, AND FORCE SENSOR TESTS. NO UNEXPECTED INSULIN FLOW BLOCKED ALARMS DURING TESTING. THE TRACE AND HISTORY FILES WERE SUCCESSFULLY DOWNLOADED USING THUMP. A REVIEW OF THE PUMP HISTORY FILE REVEALS ON 4/3/2025 THERE WERE FOUR (4) NO DELIVERY (INSULIN FLOW BLOCKED) ALARMS, LISTED BELOW: 04/03/2025 00:27:09 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) DURING A CL1 FOOD BOLUS DELIVERY. 04/03/2025 03:21:50 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) DURING A CL1GLUCOSECORRECTION DELIVERY. 04/03/2025 03:22:51 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) DURING A CL1 FOOD BOLUS DELIVERY. 04/03/2025 16:46:13 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) DURING A CL1GLUCOSECORRECTIONPLUSFOODBOLUS DELIVERY. THE PUMP WAS CUT OPEN FOR VISUAL INSPECTION. NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE WAS FOUND ON THE ELECTRONIC ASSEMBLY (PCBA 1 AND PCBA 2), MOTOR, OR FORCE SENSOR. A P-CAP LOCKS INTO PLACE INSIDE THE RESERVOIR COMPARTMENT PROPERLY. THE FOLLOWING WERE NOTED DURING A PHYSICAL INSPECTION: SCRATCHED CASE, CRACKED BATTERY COMPARTMENT, MISSING SERIAL NUMBER LABEL, CRACKED SELECT BUTTON KEYPAD OVERLAY, STAINED KEYPAD OVERLAY, PEELING KEYPAD OVERLAY, AND PILLOWING KEYPAD OVERLAY. THE PUMP PASSED ALL FUNCTIONAL TESTING. HIGH BG ANOMALY IS NOT CONFIRMED. INSULIN FLOW BLOCKED ALARM COMPLAINT IS NOT CONFIRMED. 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 THE CANNULA WAS BENT, AN INSULIN FLOW-BLOCKED ALARM, LEAKS ON THE INFUSION SET, AND HIGH BLOOD GLUCOSE. THE CUSTOMER REPORTED A BLOOD GLUCOSE VALUE OF 400 MG/DL. THE CUSTOMER REPORTED HYPERGLYCEMIA WAS TREATED WITH AN INSULIN PUMP (SUBCUTANEOUS INSULIN INFUSION). THE EVENT INVOLVED PRODUCTS MMT-332A, MMT-1884L, AND MMT-394A. TROUBLESHOOTING WAS PARTIALLY PERFORMED, AND THE CUSTOMER HAS BEEN USING THE INSULIN PUMP SYSTEM WITHIN 48 HOURS OF THE REPORTED HIGH BLOOD GLUCOSE EVENT. THE CUSTOMER WAS USED THE AUTO MODE FEATURE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. NO PRODUCT RETURN IS REQUIRED FOR MMT-332A. NO PRODUCT RETURN IS REQUIRED FOR MMT-1884L. NO PRODUCT RETURN IS REQUIRED FOR MMT-394A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1309914 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 NG3318128H

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Male Other FRN-MMT-332A-RSVR, UNOMED INF SET.