BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1884L MM780G BLE 3.0 MG/ML

    MDR report key: 19590317 · Received June 21, 2024

    Report

    Report Number
    2032227-2024-190115
    Event Type
    Malfunction
    Date Received
    June 21, 2024
    Date of Event
    June 4, 2024
    Report Date
    December 5, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000076300081937801
    PMA / PMN Number
    P160017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP WAS RECEIVED WITH CONSTANT PUMP ERROR 38 DURING THE REWIND TEST. UNABLE TO PERFORM THE DISPLACEMENT TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST, OCCLUSION TEST DUE TO CONSTANT PUMP ERROR 38. THE PUMP PASSED THE SELF TEST, SLEEP CURRENT MEASUREMENT, AND ACTIVE CURRENT MEASUREMENT. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: MINOR SCRATCHED DISPLAY WINDOW, SCRATCHED CASE, DENTED CASE AT THE BATTERY COMPARTMENT AND PILLOWING KEYPAD OVERLAY. THE PUMP DID NOT HAVE A BATTERY INSTALLED WHEN RECEIVED. NO DAMAGE NOTED ON THE ORIGINAL BATTERY CAP. HISTORY DOWNLOAD WAS SUCCESSFUL USING THUMP. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON THE PCBA1, PCBA2, FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE ON THE NGP STB3. THE PUMP ALARMED PUMP ERROR 38 ALARM WHILE TESTING THE MOTOR ON THE NGP STB3. PUMP ERROR 38 WAS CONFIRMED DURING TESTING AND IN THE PUMP HISTORY FILE, PROBLEM ISOLATED TO THE MOTOR. PLEASE SEE BELOW FOR THE PUMP ERROR(S)/ALARM(S) NOTED 2 DAYS PRIOR TO THE EVENT DATE 04-JUN-2024 IN THE PUMP HISTORY FILE. (B)(6) 2024 23:28:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: LOSTSENSOR1ALERT (780) (B)(6) 2024 23:38:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: LOSTSENSOR1ALERT (780) (B)(6) 2024 23:57:19.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: STUCKMOTORALARM (38) (B)(6) 2024 00:07:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: STUCKMOTORALARM (38) (B)(6) 2024 04:18:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: LOSTSENSOR1ALERT (780) (B)(6) 2024 04:28:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: LOSTSENSOR1ALERT (780) (B)(6) 2024 08:48:26.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: STUCKMOTORALARM (38) (B)(6) 2024 08:49:19.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: STUCKMOTORALARM (38) (B)(6) 2024 08:50:08.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: STUCKMOTORALARM (38) (B)(6) 2024 09:47:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: LOSTSENSOR1ALERT (780) (B)(6) 2024 09:57:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: LOSTSENSOR1ALERT (780) (B)(6) 2024 10:07:53.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: STUCKMOTORALARM (38) (B)(6) 2024 10:14:24.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6) 2024 10:14:49.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: POSTRESETRAMCRCALARM (23) (B)(6) 2024 10:15:04.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTOUTLIMIT (6) (B)(6) 2024 10:15:12.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTOUTLIMIT (6) UNABLE TO TEST FOR LOST SENSOR ALARM DUE TO CONSTANT PUMP ERROR 38 DURING THE REWIND TEST. CONSTANT PUMP ERROR 38 (CONFIRMED) DURING THE REWIND TEST AND WAS FOUND IN THE PUMP HISTORY FILE. PUMP ERROR 23 AND BATTERY OUT LIMIT ALARM WERE EXPECTED DUE TO THE BATTERY REMOVED AND THE PUMP'S TIME RESET. THE POWER MANAGEMENT TOOL CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WAS WITHIN SPEC RANGE. LOSTSENSOR1ALERT (780) - UNKNOWN. PUMP ERROR 38/STUCKMOTORALARM (38) - CONFIRMED DURING TESTING. PUMP ERROR 23 - NOT CONFIRMED. BATTOUTLIMIT (6) - NOT CONFIRMED. UNABLE TO PERFORM THE DISPLACEMENT TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST, OCCLUSION TEST DUE TO CONSTANT PUMP ERROR 38. THE PUMP PASSED THE SELF TEST, SLEEP CURRENT MEASUREMENT, AND ACTIVE CURRENT MEASUREMENT. PUMP ERROR 38 WAS CONFIRMED DURING TESTING AND IN THE PUMP HISTORY FILE, PROBLEM ISOLATED TO THE MOTOR. 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

    ADDITIONAL INFORMATION HAS BEEN RECEIVED BASED ON ADDITIONAL PA COMPLETION, THE UPDATED INFORMATION HAS BEEN PROVIDED IN SECTION H11 WITH THIS REPORT AS "ANALYSIS SUMMARY UPDATED ON (B)(6) 2024. PER TIECK, MARIE SR PRIN R/D ENGINEER - I RECEIVED THE FA REPORT ON THE MOTOR WE SENT BACK FROM NGP 780 DEVICE SN (B)(6) THE RESULTING ANALYSIS IS THE FAILURE IS DUE TO A BROKEN ROTOR MAGNET THAT ALSO DAMAGED THE STATOR WINDING WIRES. I HAVE ATTACHED THE FA REPORT FROM MAXON FOR YOUR REFERENCE". 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 PUMP ERROR 38. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1884L. CUSTOMER REPORTED RECEIVING A PUMP ERROR. CUSTOMER WAS ABLE TO CLEAR THE ERROR BUT WAS UNABLE TO COMPLETE THE REWIND PROCESS. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE THE USE OF THE PUMP. MMT-1884L WAS REQUESTED AND CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1157106 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 NG3763057H 000076300081937801

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male