BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    670G INSULIN PUMP MMT-1780KL

    MDR report key: 19958431 · Received August 12, 2024

    Report

    Report Number
    2032227-2024-218493
    Event Type
    Malfunction
    Date Received
    August 12, 2024
    Date of Event
    July 15, 2024
    Report Date
    October 10, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000283513
    PMA / PMN Number
    P150001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP PASSED THE SELF TEST. THE PUMP RESPONDED PROPERLY TO THE BUTTON PRESSES. NO STUCK KEY ALARM, STUCK BUTTON ALARM, BUTTON ERROR ALARM, KEYPAD UNRESPONSIVE, NUMBERS RAMPING OR SCROLLING SCREENS NOTED DURING TESTING. REMOVED THE KEYPAD GRAPHICS PANEL, NO MOISTURE DAMAGE NOTED ON THE KEYPAD TRACES. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND MOISTURE DAMAGE ON THE KEYPAD FLEX TRACES THAT CONNECTS TO THE ELECTRONIC ASSEMBLY, ON THE PCBA1, ON THE PCBA2, AND ON THE MOTOR. NO DAMAGE NOTED ON THE FORCE SENSOR. STUCK KEY ALARM (61) - CONFIRMED (FOUND IN THE PUMP HISTORY FILE ON (B)(6) 2024 23:47:04.000 AND (B)(6) 2024 23:57:00.000) DUE TO MOISTURE DAMAGE ON THE KEYPAD FLEX TRACES AND ON THE ELECTRONIC ASSEMBLY. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: MINOR SCRATCHED DISPLAY WINDOW, SCRATCHED CASE, CRACKED CASE AT THE BATTERY TUBE SIDE, SCRATCHED KEYPAD OVERLAY, PILLOWING KEYPAD OVERLAY, AND CRACKED KEYPAD OVERLAY AT THE SELECT BUTTON. THE TEST P-CAP AND RESERVOIR DOES LOCK IN PLACE IN THE RESERVOIR COMPARTMENT. HISTORY DOWNLOAD WAS SUCCESSFUL USING THUS. STUCK KEY ALARM WAS FOUND IN (B)(6) 2024 23:47:04.000 AND ON (B)(6) 2024 23:57:00.000 ON THE EVENT DATE 15-JUL-2024 IN THE PUMP HISTORY FILE. PLEASE SEE BELOW FOR THE PUMP ERROR(S)/ALARM(S) NOTED 2 DAYS PRIOR TO THE EVENT DATE 15-JUL-2024 IN THE PUMP HISTORY FILE. (B)(6) 2024 12:20:00.000 ALARMALERTNOTIFICATION; FAULTNUMBER = LOST SENSOR 1 ALERT (780). (B)(6) 2024 12:30:00.000 ALARMALERTNOTIFICATION; FAULTNUMBER = LOST SENSOR 1 ALERT (780). (B)(6) 2024 12:48:00.000 ALARMALERTNOTIFICATION; FAULTNUMBER = LOST SENSOR 2 ALERT (781). (B)(6) 2024 17:05:00.000 ALARMALERTNOTIFICATION; FAULTNUMBER = LOST SENSOR 1 ALERT (780). (B)(6) 2024 17:15:00.000 ALARMALERTNOTIFICATION; FAULTNUMBER = LOST SENSOR 1 ALERT (780). (B)(6) 2024 23:47:04.000 ALARMALERTNOTIFICATION; FAULTNUMBER = STUCK KEY ALARM (61). (B)(6) 2024 23:54:59.000 ALARMALERTNOTIFICATION; FAULTNUMBER = BATTERY REMOVED (84). (B)(6) 2024 23:55:57.000 ALARMALERTNOTIFICATION; FAULTNUMBER = BATTERY REMOVED (84). (B)(6) 2024 23:56:55.000 ALARMALERTNOTIFICATION; FAULTNUMBER = BATTERY REMOVED (84). (B)(6) 2024 23:57:00.000 ALARMALERTNOTIFICATION; FAULTNUMBER = STUCK KEY ALARM (61). (B)(6) 2024 23:57:06.000 BATTERYINSERTED, (B)(6) 2024 23:57:20.000 BATTERYREMOVED, (B)(6) 2024 23:57:20.000 ALARMALERTNOTIFICATION, FAULTNUMBER = BATTERY REMOVED (84). (B)(6) 2024 23:57:34.000 BATTERYINSERTED, (B)(6) 2024 23:59:23.000 BATTERYREMOVED, (B)(6) 2024 23:59:23.000 ALARMALERTNOTIFICATION, FAULTNUMBER = BATTERY REMOVED (84). THE PUMP PROPERLY CONNECTED WITH THE GUARDIAN LINK 3 TRANSMITTER. AFTER THE PUMP COMPLETED WARM UP AND CALIBRATION, THE PUMP WAS ABLE TO DISPLAY THE TEST BG VALUE OF 239 MG/DL ON THE PUMP'S HOME SCREEN. NO COMMUNICATION ANOMALY, CALIBRATION ANOMALY OR LOST SENSOR ALERT NOTED. LOST SENSOR ALERT - NOT CONFIRMED. STUCK KEY ALARM (61) - CONFIRMED (FOUND IN THE PUMP HISTORY FILE). BUTTON ERROR ALARM AND KEYPAD UNRESPONSIVE WAS NOT CONFIRMED DURING TESTING. HOWEVER, STUCK KEY ALARM - CONFIRMED (FOUND IN THE PUMP HISTORY FILE) DUE TO MOISTURE DAMAGE ON THE KEYPAD FLEX TRACES THAT CONNECTS TO THE ELECTRONIC ASSEMBLY AND ON THE ELECTRONIC ASSEMBLY. EXPOSED TO MOISTURE CONFIRMED. 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. 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 EXPOSED TO MOISTURE, KEYPAD/BUTTON UNRESPONSIVE/BUTTON ERROR. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1780KL. TROUBLESHOOTING WAS PERFORMED FOR THE EVENT.CUSTOMER REPORTED RECEIVING A STUCK BUTTON ALARM. TROUBLESHOOTING INDICATED THAT PUMP REQUIRES REPLACEMENT. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. MMT-1780KL WAS REQUESTED AND CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1780795 670G INSULIN PUMP MMT-1780KL AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KL HG5UV71 000000763000283513

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female