BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    640G INSULIN PUMP MMT-1712K

    MDR report key: 20589083 · Received November 1, 2024

    Report

    Report Number
    2032227-2024-262641
    Event Type
    Malfunction
    Date Received
    November 1, 2024
    Date of Event
    October 2, 2024
    Report Date
    December 23, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    000000763000317157
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP WAS RECEIVED WITH UNRESPONSIVE KEYPAD. UNABLE TO PERFORM THE SELF TEST DUE TO UNRESPONSIVE KEYPAD. UNABLE TO DOWNLOAD HISTORY FILES AND TRACES USING THUS DUE TO UNRESPONSIVE KEYPAD. THE KEYPAD OVERLAY WAS PEELED OFF AND FOUND A CORRODED KEYPAD TRACES. THE 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. A TEST CASE WAS USED AND THE ORIGINAL PCBA1, PCBA2, INTERNAL BATTERY AND MOTOR WERE INSTALLED. POWERED THE PUMP ON USING THE AA 1.5V BATTERY. THE PUMP WAS ABLE TO NAVIGATE THE MENU, CONTINUED SELF TEST AND DOWNLOAD HISTORY FILES AND TRACES USING THUS. THE PUMP PASSED THE SELF TEST. NO UNRESPONSIVE KEYPAD/KEYPAD ANOMALY NOTED WHEN USING THE TEST CASE. SUCCESSFULLY DOWNLOADED PUMP TRACES AND HISTORY FILE USING THUS. PUMP ERROR 61 (STUCK KEY ALARM) WAS FOUND ON: (B)(6) 2024 12:37:18.000, (B)(6) 2024 12:43:07.000, (B)(6) 2024 13:00:08.000 TO (B)(6) 2024 13:58:15.000, (B)(6) 2024 14:11:58.000 TO (B)(6) 2024 14:56:52.000, (B)(6) 2024 15:06:01.000 TO (B)(6) 2024 15:51:03.000, (B)(6) 2024 16:01:01.000 TO (B)(6) 2024 16:59:28.000 AND (B)(6) 2024 17:07:11.000 TO (B)(6) 2024 17:41:46.000. UNRESPONSIVE KEYPAD/PUMP ERROR 61 (STUCK KEY ALARM) WAS CONFIRMED DUE TO A CORRODED KEYPAD TRACES. PLEASE SEE BELOW FOR PUMP ERROR(S)/ALARM(S) NOTED 2 DAYS PRIOR TO THE EVENT DATE 02-OCT-2024 IN THE FORMATTED HISTORY FILE. LOST SENSOR 1 ALERT (780) WAS FOUND ON: (B)(6) 2024 11:53:00.000 AND (B)(6) 2024 12:03:00.000. LOST SENSOR 2 ALERT (781) WAS FOUND ON: (B)(6) 2024 12:22:00.000. UNABLE TO TEST FOR LOST SENSOR ALERT DUE TO UNRESPONSIVE KEYPAD. LOST SENSOR ALERT WAS UNKNOWN. INSERT BATTERY ALARM WAS FOUND ON: (B)(6) 2024 15:13:45.000, (B)(6) 2024 15:14:16.000, (B)(6) 2024 17:19:50.000, (B)(6) 2024 17:59:09.000 AND (B)(6) 2024 18:00:05.000. FAILED BATTERY ALERT/BATTERY FAILED ALARM WAS FOUND ON: (B)(6) 2024 15:13:59.000 AND (B)(6) 2024 15:15:11.000. 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 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. UNABLE TO TEST FOR FAILED BATTERY ALERT/BATTERY FAILED ALARM DUE TO UNRESPONSIVE KEYPAD. FAILED BATTERY ALERT/BATTERY FAILED ALARM WAS UNKNOWN. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A SCRATCHED CASE AND A SERIAL NUMBER LABEL MISSING. UNABLE TO PERFORM THE REQUIRED TESTING, DOWNLOAD HISTORY FILES AND TRACES USING THUS DUE TO UNRESPONSIVE KEYPAD. HOWEVER, A TEST CASE WAS USED, PERFORMED SELF TEST, DOWNLOAD HISTORY FILES AND TRACES USING THUS. UNRESPONSIVE KEYPAD/PUMP ERROR 61 (STUCK KEY ALARM) WAS CONFIRMED DUE TO A CORRODED KEYPAD TRACES. 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. THE REPORTED DEVICE IS NOT MARKETED IN THE UNITED STATES, BUT IT IS A SAME/SIMILAR DEVICE TO ONE THAT IS MARKETED INSIDE THE UNITED STATES. 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 KEYPAD/BUTTON UNRESPONSIVE/BUTTON ERROR. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1712K. TROUBLESHOOTING WAS PERFORMED. CUSTOMER REPORTED RECEIVING A STUCK BUTTON ALARM. TROUBLESHOOTING INDICATED THAT PUMP REQUIRES REPLACEMENT. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. MMT-1712K WAS REQUESTED AND CUSTOMER WILL DISCONTINUE TO USE THE INSULIN PUMP. CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632628 640G INSULIN PUMP MMT-1712K PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1712K HG4W0QN 000000763000317157

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown