BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    670G INSULIN PUMP MMT-1780KL

    MDR report key: 19698849 · Received July 9, 2024

    Report

    Report Number
    2032227-2024-199133
    Event Type
    Malfunction
    Date Received
    July 9, 2024
    Date of Event
    June 20, 2024
    Report Date
    September 2, 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
    CO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM NOTED DURING BOOT UP. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUS. UNABLE TO PERFORM DISPLACEMENT TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST, OCCLUSION TEST, SLEEP CURRENT TEST, ACTIVE CURRENT TEST DUE TO PUMP ERROR 3 DURING TESTING. PUMP FAILED SELF TEST DUE TO PUMP ERROR 75 DURING TESTING. DURING DOWNLOAD HISTORY REVIEW PUMP ERROR 3, PUMP ERROR 4, PUMP ERROR 63 AND PUMP ERROR 75 WERE RECORDED. PUMP ERROR 3 (FILE NUMBER = 2002 LINE NUMBER = 2803) WAS RECORDED ON 20-JUN-2024 AT 13:17:46 HOUR. PER ENGINEERING TROUBLESHOOT GUIDE, IT WAS DETERMINED THE PUMP ERROR 3 WAS TRIGGERED BY A HARDWARE ISSUE DUE TO PIO HIGH WAS NOT RAISED DURING EXPECTED TIME-OUT. PUMP ERROR 4 (FILE NUMBER = 32122 LINE NUMBER = 2727) AT 11:04:02 HOUR AND PUMP ERROR 63 (VARIABLE = 9, = FILE NUMBER = 32143 LINE NUMBER = 399) AT 13:17:32 BOTH ON 20-JUN-2024. PER ENGINEERING TROUBLESHOOT GUIDE, IT WAS DETERMINED THE PUMP ERROR 63 AND PUMP ERROR 4 ARE HARDWARE ISSUE DUE TO THE PIO FAILURE AND PUMP ERROR 44 IS A CONSEQUENCE ERROR OF PUMP ERROR 63. PUMP ERROR 75 OCCURRED ON 20-JUN-2024 AT 13:23:13 HOUR. PROCEEDED BY CUTTING UNIT OPEN AND PERFORM A VISUAL INSPECTION OF CONNECTORS AND ELECTRONIC STACK. PER VISUAL INSPECTION IT WAS DETERMINE THAT THE INGRESS OF WATER CORRODING ELECTRONIC ASSEMBLIES, KEYPAD FLEX CONNECTOR AND FORCE SENSOR FLEX CONNECTOR. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: CRACKED CASE, SCRATCHED CASE AND CRACKED CASE (BATTERY TUBE). IN CONCLUSION, CUSTOMER CONCERN FOR CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM WAS NOT OBSERVED DURING TESTING. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM NOT CONFIRMED. PUMP EXPOSED TO MOISTURE WAS CONFIRMED ON ELECTRONIC ASSEMBLIES. PUMP ERROR 3, 4, 63 AND 75 WERE CONFIRMED IN THE HISTORY FILE ON 20-JUN-2024 DUE TO HARDWARE ISSUE. UNABLE TO CONFIRM DEVICE TEST FAILED DUE TO MOISTURE DAMAGE ON ELECTRONIC ASSEMBLIES. 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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. 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 A CRITICAL PUMP ERROR (OPEN BOOK IMAGE), EXPOSED TO MOISTURE, DEVICE TEST FAILED. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1780KL. THE CUSTOMER REPORTED THAT THE PUMP WAS EXPOSED TO MOISTURE BUT THERE IS NO VISIBLE FLUID IN THE PUMP. THE PUMP DID NOT PASS SELF TEST. THE CUSTOMER REPORTED A CRITICAL PUMP ERROR/OPEN BOOK IMAGE ERROR. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. MMT-1780KL WAS REQUESTED AND THE CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249884 670G INSULIN PUMP MMT-1780KL AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KL NG3437248H 000000763000283513

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female