BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-1880L MM770G BLE MG

    MDR report key: 24275105 · Received February 5, 2026

    Report

    Report Number
    2032227-2026-121459
    Event Type
    Injury
    Date Received
    February 5, 2026
    Date of Event
    January 14, 2026
    Report Date
    April 8, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000076300058619502
    PMA / PMN Number
    P160017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP PASSED THE REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, AND THE DAT TEST AT .08720 INCHES. SUCCESSFULLY DOWNLOADED THE TRACE AND HISTORY FILES USING THUMP AND CARELINK UPLOAD WAS SUCCESSFUL. NO UNDER-DELIVERY ANOMALY WAS NOTED DURING TESTING. THE PUMP WAS CUT OPEN TO PERFORM A 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 SELECT BUTTON KEYPAD OVERLAY, AND PILLOWING KEYPAD OVERLAY. UNDER-DELIVERY ANOMALY IS NOT CONFIRMED. FOR ADDITIONAL INFORMATION REGARDING THE TESTS PERFORMED, REFER TO D00854230 ¿ APPENDIX E THE PUMP HISTORY FILE LISTS 12 BOLUSES ON THE EVENT DATE, 1/14/2026. PLEASE SEE BELOW FOR THE FIRST 10 BOLUSES LISTED ON THE EVENT DATE, 1/14/2026: 01/14/2026 02:26:29.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: MANUALBOLUS (0) NORMALBOLUSAMOUNTPROGRAMMED: 53000 (5.3 U) BOLUSAMOUNTDELIVERED: 53000 (5.3 U) 01/14/2026 02:48:37.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: MANUALBOLUS (0) NORMALBOLUSAMOUNTPROGRAMMED: 61000 (6.1 U) BOLUSAMOUNTDELIVERED: 61000 (6.1 U) 01/14/2026 06:58:23.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: MANUALBOLUS (0) NORMALBOLUSAMOUNTPROGRAMMED: 31000 (3.1 U) BOLUSAMOUNTDELIVERED: 31000 (3.1 U) 01/14/2026 08:07:47.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: MANUALBOLUS (0) NORMALBOLUSAMOUNTPROGRAMMED: 45000 (4.5 U) BOLUSAMOUNTDELIVERED: 45000 (4.5 U) 01/14/2026 08:58:27.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: MANUALBOLUS (0) NORMALBOLUSAMOUNTPROGRAMMED: 39000 (3.9 U) BOLUSAMOUNTDELIVERED: 39000 (3.9 U) 01/14/2026 11:54:53.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: MANUALBOLUS (0 NORMALBOLUSAMOUNTPROGRAMMED: 23000 (2.3 U) BOLUSAMOUNTDELIVERED: 23000 (2.3 U) 01/14/2026 19:21:49.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: MANUALBOLUS (0) NORMALBOLUSAMOUNTPROGRAMMED: 57000 (5.7 U) BOLUSAMOUNTDELIVERED: 57000 (5.7 U) 01/14/2026 19:41:43.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: MANUALBOLUS (0) NORMALBOLUSAMOUNTPROGRAMMED: 55000 (5.5 U) BOLUSAMOUNTDELIVERED: 55000 (5.5 U) 01/14/2026 20:02:57.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: MANUALBOLUS (0) NORMALBOLUSAMOUNTPROGRAMMED: 73000 (7.3 U) BOLUSAMOUNTDELIVERED: 73000 (7.3 U) 01/14/2026 20:51:01.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: MANUALBOLUS (0) NORMALBOLUSAMOUNTPROGRAMMED: 64000 (6.4 U) BOLUSAMOUNTDELIVERED: 64000 (6.4 U) PLEASE SEE BELOW FOR THE DAILY TOTAL OF ALL INSULIN DELIVERED ON THE EVENT DATE,1/14/2026: 01/15/2026 00:00:00.000 DAILYTOTALSG670 (63) DAILYTOTALCOLLECTIONSTARTTIME: 01/14/2026 00:00:00.000 DAILYTOTALOFALLINSULINDELIVERED: 793000 (79.3 U) DAILYTOTALOFBASALINSULINDELIVERED: 0 (0 U) DAILYTOTALOFBOLUSINSULINDELIVERED: 793000 (79.3 U) THERE WERE NO AUTO SUSPEND EVENTS ON THE EVENT DATE, 1/14/2026. PLEASE SEE BELOW FOR THE USER SUSPEND ON THE EVENT DATE, 1/14/2026: 01/14/2026 22:08:12 INSULINDELIVERYSTOPPED REASONFOINSULINDELIVERYSUSPENSION: USERSUSPENDED (2) 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 EXPERIENCED HYPERGLYCEMIA. THE CUSTOMER SAID THE PUMP WAS NOT DELIVERING BOLUS. PROCESSED PUMP REPLACEMENT. THE CUSTOMER WAS NOT CONFIDENT WITH THE PUMP ANYMORE. THE BLOOD GLUCOSE VALUE AT THE TIME OF THE EVENT WAS 360 MG/DL. THE CUSTOMER WAS TREATED WITH INSULIN PUMP (SUBCUTANEOUS INSULIN INFUSION) AND MANUAL INJECTION. THE EVENT INVOLVED PRODUCT(S) MMT-1880L, MMT-332A, AND MMT-397A. TROUBLESHOOTING WAS PARTIALLY PERFORMED. THE CUSTOMER WAS NOT USING THE AUTO MODE/SMART GUARD FEATURE AT THE TIME OF THE EVENT. THE CUSTOMER WAS USING THE INSULIN PUMP SYSTEM WITHIN 48 HOURS OF THE REPORTED EVENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE CUSTOMER WILL DISCONTINUE USE OF THE INSULIN PUMP. MMT-1880L WAS REQUESTED, AND THE CUSTOMER RESPONSE WAS THAT THE DEVICE WILL BE RETURNED. NO PRODUCT RETURN IS REQUIRED FOR MMT-332A. NO PRODUCT RETURN IS REQUIRED FOR MMT-397A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336259 PUMP MMT-1880L MM770G BLE MG AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1880L NG3998942H 000076300058619502

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Other FRN-MMT-332A-RSVR, UNOMED INF SET.