BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1884L MM780G BLE 3.0 MG/ML

    MDR report key: 20563916 · Received October 29, 2024

    Report

    Report Number
    2032227-2024-261730
    Event Type
    Malfunction
    Date Received
    October 29, 2024
    Date of Event
    August 31, 2024
    Report Date
    October 29, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    PMA / PMN Number
    P160017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    003

    Narratives

    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. P-CAP LOCKED IN PLACE PROPERLY DURING TESTING. UNIT WAS SUCCESSFULLY DOWNLOADED USING (THUMP SOFTWARE). THE ADAPT TOOL WAS UTILIZED TO SEARCH FOR ALARMS THAT MAY HAVE OCCURRED IN THE PAST OR DURING COMPLAIN CALL THAT MIGHT OF TRIGGER THE REASON COMPLAIN. UNIT PASSED THE DISPLACEMENT TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST, OCCLUSION TEST. NO PUMP ERROR 41 ALARM NOTED DURING TESTING. THE ADAPT TOOL RECORDED ONE TIME OCCURRENCE OF PUMP ERROR 41 ON (B)(6) 2024 08:18:42.000. THE ADAPT TOOL ALSO RECORDED PUMP ERROR 43 ON (B)(6) 202408:18:42.000. UNIT WAS CUT OPEN AND PERFORM A VISUAL INSPECTION ON CONNECTORS AND ELECTRONIC ASSEMBLIES. PER VISUAL INSPECTION ALL CONNECTORS INCLUDING MOTOR FLEX CONNECTOR WERE PLUGGED IN PROPERLY. NO MOISTURE DAMAGE OR PHYSICAL DAMAGE NOTED DURING VISUAL INSPECTION. HOWEVER, DURING VISUAL INSPECTION UNDER MICROSCOPE CRACKED MOTOR FLEX CONNECTOR TRACES WERE NOTED CAUSING AN INTERMITTENT PUMP ERROR 41 DURING TESTING. ISOLATE TO MOTOR. IN CONCLUSION NO PUMP ERROR ALARM 41 OR PUMP ERROR 41 WAS NOTED DURING TESTING. UNIT MAY HAVE HAD AN INTERMITTENT FAILURE NOT DETECTED DURING OUR TESTING. IN ADDITION CRACKED MOTOR FLEX TRACES WERE NOTED DURING VISUAL INSPECTION UNDER MICROSCOPE. COSMETIC DAMAGE CONFIRMED WHEN CRACKED CASE ON BATTERY TUBE WAS OBSERVED. 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 PUMP ERROR 41 - (MOTOR POWER SUPPLY VOLTAGE ERROR DETECTED. THIS IS MEASURED BEFORE EACH SINGLE PUMP STROKE, AND THEN CONTINUALLY MEASURED PERIODICALLY DURING THE ENTIRE MOTOR DRIVING PERIOD), AND PUMP ERROR 43 - (AN ERROR IN THE MOTOR WAS DETECTED BY READING UNEXPECTED VALUE FROM HALL SENSOR), AND PUMP HAD DAMAGE. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1884L. TROUBLESHOOTING WAS PERFORMED FOR THE EVENT. CUSTOMER REPORTED RECEIVING A PUMP ERROR. TROUBLESHOOTING DETERMINED THAT ISSUE WAS POSSIBLY CAUSED BY A SITE ISSUE AS ERROR DID NOT RECUR AFTER REWINDING PUMP AND COMPLETING REWIND/PRIME PROCESS AGAIN WITH SAME SET. CUSTOMER REPORTED PHYSICAL DAMAGE (CRACK OR SCRATCH) ON THE PUMP NOT RELATED TO THE RETAINER RING. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. MMT-1884L WAS REQUESTED AND CUSTOMER RESPONSE WAS THE DEVICE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1042987 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 HG6FY58

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male