BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1781K 670G V4.11 MG

    MDR report key: 19890157 · Received August 2, 2024

    Report

    Report Number
    2032227-2024-214110
    Event Type
    Malfunction
    Date Received
    August 2, 2024
    Date of Event
    July 16, 2024
    Report Date
    October 23, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    PMA / PMN Number
    P160017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PUMP PASSED THE SELF TEST, SLEEP CURRENT MEASUREMENT AND ACTIVE CURRENT MEASUREMENT. PUMP WAS MONITORED, NO UNEXPECTED BATTERY POWER LOSS AND KEYPAD ANOMALY/STUCK BUTTON ALARM NOTED. SUCCESSFULLY DOWNLOADED PUMP TRACES AND HISTORY FILE USING THUS. 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. INSERT BATTERY ALARM WAS FOUND ON: (B)(6) 2024 19:23:43.000, (B)(6) 2024 19:50:08.000, (B)(6) 2024 20:55:24.000, (B)(6) 2024 21:07:28.000, (B)(6) 2024 22:49:41.000, (B)(6) 2024 23:53:00.000, (B)(6) 2024 23:53:10.000, (B)(6) 2024 23:53:28.000, (B)(6) 2024 01:56:26.000, FAILED BATTERY ALERT/BATTERY FAILED ALARM WAS FOUND ON: (B)(6) 2024 19:49:42.000, (B)(6) 2024 19:50:00.000, (B)(6) 2024 23:53:04.000, POWER LOSS ALARM WAS FOUND ON: (B)(6) 2024 19:51:28.000, (B)(6) 2024 20:01:01.000, (B)(6) 2024 21:06:21.000, (B)(6) 2024 21:06:32.000, (B)(6) 2024 21:09:07.000, (B)(6) 2024 21:09:19.000, (B)(6) 2024 01:56:56.000, (B)(6) 2024 01:57:07.000, PUMP ERROR 23 ALARM POWER LOSS ALARM WAS FOUND ON: (B)(6) 2024 21:06:04.000, (B)(6) 2024 21:07:42.000, (B)(6) 2024 01:56:43.000. 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 WAS EXPECTED DUE TO PUMP BATTERY DOES NOT HAVE ENOUGH POWER. THE CUSTOMER HAD USED A NO POWER/DEPLETED BATTERY. PUMP ERROR 23 ALARM AND POWER LOSS ALARM WERE EXPECTED SINCE THE PUMP RESETS AFTER THE BATTERY WAS REMOVED FOR MORE THAN 10 MINUTES. NO UNEXPECTED FAILED BATTERY ALERT/BATTERY FAILED ALARM, PUMP ERROR 23 ALARM AND POWER LOSS ALARM NOTED DURING TESTING. PLEASE SEE BELOW FOR PUMP ERROR(S)/ALARM(S) NOTED 1 WEEK PRIOR TO THE EVENT DATE 16-JUL-2024 IN THE FORMATTED HISTORY FILE. PUMP ERROR 61 (STUCK KEY ALARM) WAS FOUND ON: (B)(6) 2024 19:22:15.000, (B)(6) 2024 19:32:00.000, (B)(6) 2024 19:54:30.000, (B)(6) 2024 20:02:44.000, (B)(6) 2024 20:06:12.000, (B)(6) 2024 20:09:29.000, (B)(6) 2024 20:13:55.000, (B)(6) 2024 20:17:10.000, (B)(6) 2024 20:20:17.000, (B)(6) 2024 20:58:28.000. ALL BUTTONS FUNCTION PROPERLY. THE KEYPAD OVERLAY WAS REMOVED TO PERFORM VISUAL INSPECTION AND NO DAMAGE IN THE KEYPAD ASSEMBLY NOTED. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND CORROSION ON THE J1/PCBA 1 CONNECTOR. NO CORROSION OR MOISTURE DAMAGE FOUND ON THE PCBA 2, FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. KEYPAD ANOMALY/PUMP ERROR 61 (STUCK KEY ALARM) WAS CONFIRMED ACCORDING IN THE FORMATTED HISTORY FILE DUE TO CORROSION ON THE J1/PCBA 1 CONNECTOR. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A CRACKED CASE, A SCRATCHED CASE AND A SERIAL NUMBER LABEL MISSING. CUSTOMER ALLEGED FOR UNEXPECTED BATTERY POWER LOSS WAS NOT CONFIRMED. HOWEVER, KEYPAD ANOMALY/PUMP ERROR 61 (STUCK KEY ALARM) WAS CONFIRMED ACCORDING IN THE FORMATTED HISTORY FILE DUE TO CORROSION ON THE J1/PCBA 1 CONNECTOR. 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. SELECT PATIENT INFORMATION CANNOT BE PROVIDED DUE TO REGIONAL PRIVACY REGULATIONS. 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 REPORTED THAT THE INSULIN PUMP WAS SHUT OFF AND CANNOT SHUT ON ANYMORE. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1781K. TROUBLESHOOTING WAS PERFORMED, CUSTOMER REPORTED RECEIVING A STUCK BUTTON ALARM. TROUBLESHOOTING INDICATED THAT PUMP REQUIRES REPLACEMENT. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. MMT-1781K WAS REQUESTED AND CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740029 PUMP MMT-1781K 670G V4.11 MG AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1781K NG3394580H

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Unknown