BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    670G INSULIN PUMP MMT-1780KL

    MDR report key: 20725017 · Received November 19, 2024

    Report

    Report Number
    2032227-2024-271621
    Event Type
    Malfunction
    Date Received
    November 19, 2024
    Date of Event
    November 4, 2024
    Report Date
    January 30, 2025
    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
    KY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP PASSED THE FUNCTIONAL TESTS, 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 DAT AT 0.08750 INCHES. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUS. PLEASE SEE BELOW FOR THE DATE RANGE LISTED IN THE FORMATTED HISTORY FILE. THE FORMATTED HISTORY FILE LISTS DATA FROM 05/16/2024 TO 10/29/2024. THERE WAS NO DATA AVAILABLE TO VERIFY FAILED BATTERY ALERT/BATTERY FAILED ALARM AND E/A ALARM OR PUMP ERROR(S)/ALARM(S) 1 WEEK PRIOR TO THE EVENT DATE 04-NOV-2024 IN THE FORMATTED HISTORY FILE. 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. HOWEVER, INSERT BATTERY ALARM WAS FOUND ON: 10/28/2024 13:07:34.000 FAILED BATTERY ALERT/BATTERY FAILED ALARM WAS FOUND ON: 10/28/2024 12:58:42.000, 10/28/2024 13:04:29.000, 10/28/2024 13:04:54.000, 10/28/2024 13:05:09.000. POWER LOSS ALARM WAS FOUND ON: 10/28/2024 13:08:03.000, 10/28/2024 13:08:13.000. INSERT BATTERY ALARM WAS EXPECTED SINCE THE BATTERY WAS REMOVED FROM THE PUMP. UPON CHECKING ON THE POWER DATA/DETAIL TRACE FILE, FAILED BATTERY ALERT/BATTERY FAILED ALARM AND POWER LOSS ALARM WERE EXPECTED DUE TO PUMP BATTERY DOES NOT HAVE ENOUGH POWER. THE CUSTOMER HAD USED A NO POWER/DEPLETED BATTERY. NO UNEXPECTED FAILED BATTERY ALERT/BATTERY FAILED ALARM AND POWER LOSS ALARM NOTED DURING THE TESTING. PLEASE SEE BELOW FOR PUMP ERROR(S)/ALARM(S) NOTED 1 WEEK PRIOR SURROUNDING THE DATE OF 29-OCT -2024 LISTED IN THE FORMATTED HISTORY FILE. PUMP ERROR 4 ALARM WAS FOUND ON: 10/28/2024 12:58:37.000 10/28/2024 13:05:17.000 PUMP ERROR 63 ALARM (VARIABLEINFO = 0C) WAS FOUND ON: 10/28/2024 12:58:39.000 PUMP ERROR 4 ALARM AND PUMP ERROR 63 ALARM (VARIABLEINFO = 0C) WERE CONFIRMED ACCORDING IN THE FORMATTED HISTORY FILE, SUSPECTED ON HW. PUMP ERROR 53 ALARM (FILE NUMBER: 2005 LINE NUMBER: 5632) 10/28/2024 13:04:51.000. PUMP ERROR 53 ALARM (FILE NUMBER: 2005 LINE NUMBER: 5632) WAS CONFIRMED ACCORDING IN THE FORMATTED HISTORY FILE, SUSPECTED ON SW. PUMP ERROR 68 ALARM WAS FOUND ON: 10/28/2024 13:05:19.000. PUMP ERROR 49 ALARM WAS FOUND ON: 10/28/2024 13:05:19.000, 10/28/2024 13:05:47.000. PUMP ERROR 23 ALARM WAS FOUND ON: 10/28/2024 13:06:24.000, 10/28/2024 13:07:49.000. PUMP ERROR 68 ALARM, PUMP ERROR 49 ALARM AND PUMP ERROR 23 ALARM WERE EXPECTED SINCE THE PUMP RESTARTED DUE TO PUMP ERROR 53 ALARM (FILE NUMBER: 2005 LINE NUMBER: 5632). THE PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND CORROSION ON THE PCBA 1, PCBA 2, FORCE SENSOR, MOTOR AND VIBRATOR¿ASSEMBLY NOTED. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A MISSING DISPLAY WINDOW/COVER, A CRACKED KEYPAD OVERLAY, A KEYPAD OVERLAY PEELING, A SCRATCHED CASE, A CRACKED CASE-CORNER OF BELT CLIP RAILS NEAR THE BATTERY TUBE COMPARTMENT, A SERIAL NUMBER LABEL MISSING AND A BROKEN BELT CLIP RAILS. THE PUMP PASSED ALL THE REQUIRED TESTING. CUSTOMER ALLEGED FOR FAILED BATTERY ALERT/BATTERY FAILED ALARM WAS NOT CONFIRMED. HOWEVER, PUMP ERROR 53 ALARM (FILE NUMBER: 2005 LINE NUMBER: 5632) WAS CONFIRMED ACCORDING IN THE FORMATTED HISTORY FILE, SUSPECTED ON SW. ALSO, PUMP ERROR 4 ALARM AND PUMP ERROR 63 ALARM (VARIABLEINFO = 0C) WERE CONFIRMED ACCORDING IN THE FORMATTED HISTORY FILE DUE TO CORROSION ON THE PCBA 1 AND PCBA 2. DURING VISUAL INSPECTION, CORROSION WAS ALSO FOUND ON THE FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. 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. 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 THE BATTERY FAILURE ALARM, PUMP FAILURE ALARM, AND THE PUMP WAS UNRESPONSIVE THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1780KL. TROUBLESHOOTING WAS NOT PERFORMED, AND THE ISSUE WAS NOT RESOLVED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. IT WAS UNKNOWN WHETHER THE CUSTOMER WILL CONTINUE USING THE DEVICE, AND NO PRODUCT RETURN IS REQUIRED FOR MMT-1780KL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91760 670G INSULIN PUMP MMT-1780KL AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KL HG44PUD 000000763000283513

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Male