BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    640G INSULIN PUMP MMT-1712K

    MDR report key: 20998942 · Received December 23, 2024

    Report

    Report Number
    2032227-2024-292606
    Event Type
    Malfunction
    Date Received
    December 23, 2024
    Date of Event
    November 27, 2024
    Report Date
    March 6, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PUMP WAS RECEIVED WITH A CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. UNABLE TO PERFORM THE DISPLACEMENT TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST, OCCLUSION TEST, SLEEP CURRENT MEASUREMENT TEST, ACTIVE CURRENT MEASUREMENT TEST AND SELF TEST DUE TO CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND CORRODED PCBA 1, PCBA 2 AND FORCE SENSOR. SUCCESSFULLY UTILIZED CREST AND THUS TO DOWNLOAD HISTORY FILES, TRACES AND COMLINK3 FILES. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM CONFIRMED AND WAS TRIGGERED BY A PUMP ERROR 35 FATAL ALARM CONFIRMED IN THE HISTORY FILES ON 11/27/2024 13:54:00.000 AND ON 11/27/2024 14:04:00.000 DUE TO CORRODED FORCE SENSOR.TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: MINOR SCRATCHED DISPLAY WINDOW, SCRATCHED CASE, CRACKED BATTERY TUBE THREADS, CRACKED CASE AT THE BATTERY TUBE SIDE, CRACKED CASE AT CORNER OF THE BELT CLIP RAIL, PILLOWING KEYPAD OVERLAY, CRACKED KEYPAD OVERLAY AT THE SELECT BUTTON AND CORRODED BATTERY TUBE. PLEASE SEE BELOW FOR THE PUMP ERROR(S)/ALARM(S) NOTED 2 DAYS PRIOR TO THE EVENT DATE 27-NOV-2024 IN THE PUMP HISTORY FILE. 1/26/2024 10:22:00.000 ALARMALERTNOTIFICATION FAULTNUMBER = LOW BATTERY ALERT (104) 11/26/2024 10:25:24.000 BATTERYREMOVED 11/26/2024 10:25:24.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATTERY REMOVED (84) 11/26/2024 10:25:53.000 BATTERYINSERTED 11/27/2024 13:54:00.000 ALARMALERTNOTIFICATION FAULTNUMBER = BROKEN FORCE SENSOR ERROR (35) 11/27/2024 14:04:00.000 ALARMALERTNOTIFICATION FAULTNUMBER = BROKEN FORCE SENSOR ERROR (35) 11/27/2024 14:23:02.000 BATTERYREMOVED 11/27/2024 14:23:02.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATTERY REMOVED (84) LOW BATTERY ALERT WAS EXPECTED DUE TO THE CUSTOMER'S BATTERY IN THE PUMP IS LOW ON POWER. LOW BATTERY ALERT (104) NOT CONFIRMED. PUMP ERROR 35 CONFIRMED. UNABLE TO PERFORM THE REQUIRED TESTING DUE TO CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM WITH AUDIO TONE ALERT CONFIRMED DUE TO FATAL ALARM PUMP ERROR 35. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM AND PUMP ERROR 35 ALARM CONFIRMED DUE TO CORRODED FORCE SENSOR. 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 PUMP ERROR 35 (A BROKEN FORCE SENSOR WAS DETECTED DURING SEATING OR REGULAR DELIVERY). THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1712K. TROUBLESHOOTING WAS PERFORMED. CUSTOMER REPORTED A CRITICAL PUMP ERROR OTHER THAN THE OPEN BOOK IMAGE ERROR OR CRITICAL PUMP ERROR 24. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. CUSTOMER WILL DISCONTINUE THE USE OF INSULIN PUMP. MMT-1712K WAS REQUESTED AND CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2627923 640G INSULIN PUMP MMT-1712K PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1712K HG6C16K

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown