BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    670G INSULIN PUMP MMT-1780KL

    MDR report key: 17571497 · Received August 18, 2023

    Report

    Report Number
    2032227-2023-257156
    Event Type
    Malfunction
    Date Received
    August 18, 2023
    Date of Event
    July 28, 2023
    Report Date
    October 6, 2023
    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
    UT, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM NOTED DURING BOOT UP. THE PUMP PASSED THE DISPLACEMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST, OCCLUSION TEST, ACTIVE CURRENT TEST, AND SELF TEST. PUMP FAILS SLEEP CURRENT TEST. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUS. NO FATAL CRITICAL ALARMS OR THREE CONSECUTIVE CRITICAL HANDLING ALARMS FOUND IN THE HISTORY FILES OR TRACES. THE FOLLOWING ALARM/ALERTS WERE NOTED ON EVENT DATE: PUMP ERROR 63 VARIABLE 21 ON 07/28/2023 06:30:01.000, PUMP ERROR 68 ON 07/28/2023 06:30:03.000, PUMP ERROR 49 ON 07/28/2023 06:30:03.000, PUMP ERROR 23 ON 07/28/2023 06:31:00.000. CONFIRMED PUMP ERROR 63 VAR 21 DUE TO HARDWARE ERROR. THE FOLLOWING ALARMS/ALERTS WERE NOTED DURING ANALYSIS: PUMP ERROR 75 ON 07/28/2023 10:07:04.000. THE POWER MANAGEMENT TOOL CONFIRMED INDICATED ABNORMAL BEHAVIOR OF THE LITHIUM BACKUP BATTERY LOADED VOLTAGE (LOADED VLITH) DUE TO MOISTURE DAMAGE. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND MOISTURE DAMAGE ON PCBA 1, PCBA 2, MOTOR, FORCE SENSOR, LCD CONNECTOR, LITHIUM BATTERY CONNECTOR, AND KEYPAD CONNECTOR. UNABLE TO PERFORM FORCE SENSOR ZERO OFFSET DUE TO MOISTURE DAMAGE ON FORCE SENSOR CONNECTOR. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: CRACKED KEYPAD OVERLAY, STAINED KEYPAD OVERLAY, CRACKED CASE-CORNER OF BELT CLIP RAILS, PILLOWING KEYPAD OVERLAY, AND PEELING SERIAL NUMBER LABEL. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM WAS NOT OBSERVED DURING TESTING. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM NOT CONFIRMED. PUMP ERROR 63 CONFIRMED DUE TO HARDWARE ERROR, ISOLATED TO ELECTRONIC STACK. NO UNEXPECTED PUMP ERROR 68, 49, OR 23 NOTED DURING ANALYSIS, PUMP ERROR 68, 49, AND 23 NOT CONFIRMED. PUMP ERROR 75 CONFIRMED DUE TO MOISTURE DAMAGE. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    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, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Description of Event or Problem · 0

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER RECEIVED CRITICAL PUMP ERROR OPEN BOOK IMAGE. THE CUSTOMER STATED THAT PUMP WAS EXPOSED TO MOISTURE. TROUBLESHOOTING WAS PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER DISCONTINUE TO USE THE DEVICE AND THE PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2331244 670G INSULIN PUMP MMT-1780KL AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KL HG5D0SE 000000763000283513

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male