BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1884L MM780G BLE 3.0 MG/ML

    MDR report key: 20854398 · Received December 5, 2024

    Report

    Report Number
    2032227-2024-280325
    Event Type
    Malfunction
    Date Received
    December 5, 2024
    Date of Event
    November 11, 2024
    Report Date
    February 10, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    PMA / PMN Number
    P160017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP PASSED THE SELF TEST AND ACTIVE CURRENT MEASUREMENT. HOWEVER, THE PUMP HAD A HIGH SLEEP CURRENT MEASUREMENT. THE PUMP WAS MONITORED FOR SEVERAL DAYS WITH A NEW TEST AA 1.5V BATTERY TO ENABLE THE PUMP TO CHARGE. A BATTERY SIMULATOR WAS USED AND CONTINUED TESTING. STILL, THE PUMP HAD A HIGH SLEEP CURRENT MEASUREMENT. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUMP. POWER MANAGEMENT GRAPH WAS SUCCESSFULLY GENERATED. THE POWER MANAGEMENT TOOL CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WERE WITHIN SPEC RANGE. THERE WAS NO FAILED BATTERY ALERT/BATTERY FAILED ALARM RECODED IN THE FORMATTED HISTORY FILE. THERE WAS NO BATTERY RELATED ALARMS OR ALERTS RECORDED IN THE FORMATTED HISTORY FILE ON OR BEFORE THE EVENT DATE 11-NOV-2024. NO UNEXPECTED FAILED BATTERY ALERT/BATTERY FAILED ALARM OR BATTERY RELATED ALARMS OR ALERTS NOTED DURING TESTING. PLEASE SEE BELOW FOR PUMP ERROR(S)/ALARM(S) NOTED 1 WEEK PRIOR TO THE EVENT DATE 11-NOV-2024 IN THE FORMATTED HISTORY FILE.  SENSORERRORALERT (801) WAS FOUND ON: (B)(6) 2024 19:17:57.000 LOSTSENSOR1ALERT (780) WAS FOUND ON: (B)(6) 2024 05:10:00.000, (B)(6) 2024 07:20:00.000, (B)(6) 2024 07:30:00.000, (B)(6) 202418:04:00.000, (B)(6) 2024 23:10:00.000, (B)(6) 2024 23:20:00.000, (B)(6) 2024 01:55:00.000, (B)(6) 2024 03:00:00.000, (B)(6) 2024 04:30:00.000, (B)(6) 2024 05:50:00.000, (B)(6) 2024 06:30:00.000, (B)(6) 2024 00:50:00.000, (B)(6) 2024 23:31:00.000, (B)(6) 2024 07:20:00.000, (B)(6) 2024 07:30:00.000, (B)(6) 2024 10:45:00.000. THE PUMP WAS PROGRAMMED WITH A TEST GUARDIAN LINK (3) TRANSMITTER AND A GLUCOSE SENSOR SIMULATOR. THE PUMP CONNECTED SUCCESSFULLY TO THE TRANSMITTER AND DISPLAYED ¿TRANSMITTER CONNECTION SUCCESSFUL¿. THE PUMP COMMUNICATED PROPERLY WITH GLUCOSE SENSOR SIMULATOR AND DISPLAYED THE CALIBRATE YOUR SENSOR ALARM PROPERLY AFTER COMPLETION OF THE WARM UP. THE PUMP CALIBRATED AND DISPLAYED THE PROGRAMMED VALUE OF 239 MG/DL PROPERLY ON THE DISPLAY GRAPH. NO SENSOR ERROR ALERT, LOST SENSOR ALERT OR UNEXPECTED SENSOR ERRORS OR ANOMALIES WERE NOTED DURING TESTING. THE PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON THE PCBA 1, PCBA 2, FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. THE ORIGINAL PCBA 1 WAS DISCONNECTED/RECONNECTED WITH THE ORIGINAL PCBA 2, CASE, INTERNAL BATTERY AND MOTOR. POWERED THE PUMP ON USING THE BATTERY SIMULATOR AND NO HIGH SLEEP CURRENT MEASUREMENT NOTED. AN INTERMITTENT HIGH SLEEP CURRENT MEASUREMENT WAS CONFIRMED, SUSPECTED ON THE PCBA 1/PCBA 2. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A CRACKED BATTERY TUBE THREADS, A SCRATCHED CASE AND A CRACKED CASE-CORNER OF BELT CLIP RAILS NEAR THE BATTERY TUBE COMPARTMENT. CUSTOMER ALLEGED FOR FAILED BATTERY ALERT/BATTERY FAILED ALARM WAS NOT CONFIRMED. HOWEVER, AN INTERMITTENT HIGH SLEEP CURRENT MEASUREMENT WAS CONFIRMED, SUSPECTED ON THE PCBA 1/PCBA 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

    (B)(4). 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 CHANGE SENSOR/BAD SENSOR, FAILED BATTERY TEST. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-7040A, MMT-1884L. TROUBLESHOOTING WAS NOT PERFORMED. REFER TO THE EVENT DESCRIPTION FOR MORE DETAILS. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. 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
    2114495 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 NG3247252H

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female