BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1885A OUS BLE PUMP MMOL/L

    MDR report key: 21572566 · Received March 11, 2025

    Report

    Report Number
    2032227-2025-133740
    Event Type
    Malfunction
    Date Received
    March 11, 2025
    Date of Event
    February 10, 2025
    Report Date
    May 20, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 .08750 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. MOISTURE DAMAGE WAS FOUND ON THE ELECTRONIC ASSEMBLY (PCBA 1 AND PCBA 2). 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, STAINED KEYPAD OVERLAY, PEELING SERIAL NUMBER LABEL, PILLOWING KEYPAD OVERLAY, CRACKED BATTERY COMPARTMENT AT THE CORNER OF THE BELT CLIP RAILS, AND CRACKED BATTERY TUBE THREADS. THE PUMP PASSED ALL FUNCTIONAL TESTING. UNDER-DELIVERY AND HIGH BG ANOMALIES ARE NOT CONFIRMED. MOISTURE DAMAGE WAS FOUND DURING A VISUAL INSPECTION. THE PUMP HISTORY FILE LISTS 188 BOLUSES ON THE DAY PRIOR TO THE EVENT DATE, 2/9/2025, EVENT DATE OF 2/10/2025. PLEASE SEE BELOW FOR THE FIRST 10 BOLUSES LISTED ON THE DAY PRIOR TO THE EVENT DATE, 2/9/2025, EVENT DATE OF 2/10/2025: 02/09/2025 00:00:33.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5) NORMALBOLUSAMOUNTPROGRAMMED: 2250 (0.225 U) BOLUSAMOUNTDELIVERED: 2250 (0.225 U) 02/09/2025 00:05:29.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5) NORMALBOLUSAMOUNTPROGRAMMED: 2000 (0.2 U) BOLUSAMOUNTDELIVERED: 2000 (0.2 U) 02/09/2025 00:10:33.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5) NORMALBOLUSAMOUNTPROGRAMMED: 2250 (0.225 U) BOLUSAMOUNTDELIVERED: 2250 (0.225 U) 02/09/2025 00:15:31.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5) NORMALBOLUSAMOUNTPROGRAMMED: 2000 (0.2 U) BOLUSAMOUNTDELIVERED: 2000 (0.2 U) 02/09/2025 00:20:31.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5) NORMALBOLUSAMOUNTPROGRAMMED: 2000 (0.2 U) BOLUSAMOUNTDELIVERED: 2000 (0.2 U) 02/09/2025 00:25:33.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5) NORMALBOLUSAMOUNTPROGRAMMED: 2250 (0.225 U) BOLUSAMOUNTDELIVERED: 2250 (0.225 U) 02/09/2025 00:30:31.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5) NORMALBOLUSAMOUNTPROGRAMMED: 2000 (0.2 U) BOLUSAMOUNTDELIVERED: 2000 (0.2 U) 02/09/2025 00:35:43.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: CL1AUTOBOLUS (9) NORMALBOLUSAMOUNTPROGRAMMED: 5000 (0.5 U) BOLUSAMOUNTDELIVERED: 5000 (0.5 U) 02/09/2025 00:40:31.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5) NORMALBOLUSAMOUNTPROGRAMMED: 2000 (0.2 U) BOLUSAMOUNTDELIVERED: 2000 (0.2 U) 02/09/2025 00:45:25.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5) NORMALBOLUSAMOUNTPROGRAMMED: 750 (0.075 U) BOLUSAMOUNTDELIVERED: 750 (0.075 U) PLEASE SEE BELOW FOR THE DAILY TOTAL OF ALL INSULIN DELIVERED ON THE DAY PRIOR TO THE EVENT DATE, 2/9/2025, EVENT DATE OF 2/10/2025: 02/10/2025 00:00:00.000 DAILYTOTALSG670 (63) DAILYTOTALCOLLECTIONSTARTTIME: 02/09/2025 00:00:00.000 DAILYTOTALOFALLINSULINDELIVERED: 692250 (69.225 U) DAILYTOTALOFBASALINSULINDELIVERED: 281500 (28.15 U) DAILYTOTALOFBOLUSINSULINDELIVERED: 410750 (41.075 U) THERE WERE NO AUTO SUSPEND EVENTS ON THE DAY PRIOR TO THE EVENT DATE, 2/9/2025, EVENT DATE OF 2/10/2025. PLEASE SEE BELOW FOR THE USER SUSPEND ON THE DAY PRIOR TO THE EVENT DATE, 2/9/2025, EVENT DATE OF 2/10/2025: 02/09/2025 22:42:00 INSULINDELIVERYSTOPPED REASONFORINSULINDELIVERYSUSPENSION = USER SUSPENDED 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. 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. 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. 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 AND REPORTED INSULIN PUMP WAS NOT BLOUSING. THE CUSTOMER BLOOD GLUCOSE WAS 20.1 MMOL/L AND THE HYPERGLYCEMIC EVENT WAS TREATED WITH MANUAL INJECTION/INSULIN PEN. THE EVENT INVOLVED PRODUCT MMT-1885A. TROUBLESHOOTING WAS PERFORMED FOR HYPERGLYCEMIC EVENT. CUSTOMER WAS USING THE INSULIN PUMP SYSTEM WITHIN 48HOURS OF REPORTED EVENT. CUSTOMER WAS USING THE AUTO MODE/SMARTGUARD FEATURE AT THE TIME OF THE EVENT AND INSULIN PUMP PASSED SELF TEST. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND THE INSULIN PUMP WILL BE REPLACED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. MMT-1885A WAS REQUESTED AND CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1204647 PUMP MMT-1885A OUS BLE PUMP MMOL/L AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1885A NG3287205H

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Unknown