BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    630G INSULIN PUMP MMT-1715KL 630G

    MDR report key: 15950370 · Received December 9, 2022

    Report

    Report Number
    2032227-2022-374318
    Event Type
    Malfunction
    Date Received
    December 9, 2022
    Date of Event
    November 18, 2022
    Report Date
    March 24, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    000000763000316655
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER RETURNED PUMP FOR ALLEGED NO DELIVERY/OCCLUSION ALARM DURING THERAPY AND UNRESPONSIVE KEYPAD FOUND ON 18-NOV-2022. PUMP WAS RECEIVED WITH INTERMITTENTLY UNRESPONSIVE MIDDLE AND BACK BUTTONS. THE PUMP PASSED THE DISPLACEMENT TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST, AND OCCLUSION TEST. THE PUMP FAILED THE SELF TEST; PUMP ALARMED A PUMP ERROR 63 DURING SELF TEST. THE PUMP PASSED THE KEYPAD VOLTAGE TEST. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO THE RESERVOIR COMPARTMENT. SUCCESSFULLY DOWNLOADED PUMP HISTORY FILES AND TRACES USING THUS SOFTWARE. PUMP ALARMED A NO DELIVERY ALARM ON THE EVENT DATE OF 11/18/2022 AT 01:11:30.000 DURING BOLUS. PUMP ALARMED A PUMP ERROR 63 (VARIABLE # 3) DURING TESTING ON 02/27/2023 AT 09:50:20.000 OR 9:50:20 AM DUE TO BROKEN TRACES ON THE U1 CHIP AT THE KEYPAD ASSEMBLY ON PINS # 6 SDA AND #1 VDD. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND BROKEN TRACES ON THE U1 CHIP AT THE KEYPAD ASSEMBLY ON PINS # 6 SDA AND #1 VDD, MOISTURE DAMAGE ON KEYPAD TRACE, MOISTURE DAMAGE ON THE FORCE SENSOR, MOISTURE DAMAGE ON MOTOR FLEX CABLE, AND MOISTURE DAMAGE ON PCBA 1 AND PCBA 2. THE FOLLOWING WERE ALSO NOTED DURING VISUAL INSPECTION: BATTERY TUBE THREADS - CRACKED, SCRATCHED CASE, CRACKED CASE, CRACKED CASE (BATTERY TUBE), CRACKED CASE-CORNER OF BELT CLIP RAILS, CRACKED KEYPAD OVERLAY, STAINED KEYPAD OVERLAY, PILLOWING KEYPAD OVERLAY, LABEL DAMAGE, CORRODED BATTERY TUBE, AND CORRODED BATTERY TUBE SPRING. NO DELIVERY/OCCLUSION ALARM DURING THERAPY WAS NOT CONFIRMED DURING TESTING. UNRESPONSIVE KEYPAD WAS CONFIRMED DURING TESTING DUE TO MOISTURE DAMAGE ON THE KEYPAD TRACE. PUMP ERROR 63 WAS CONFIRMED DURING TESTING DUE TO BROKEN TRACES ON THE U1 CHIP AT THE KEYPAD ASSEMBLY ON PINS # 6 SDA AND #1 VDD. MOISTURE DAMAGE WAS CONFIRMED FOUND ON THE ELECTRONIC ASSEMBLY, FORCE SENSOR, MOTOR, KEYPAD TRACES, AND BATTERY TUBE. 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

    (B)(4). 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. 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 THE CUSTOMER REPORTS UNRESPONSIVE BUTTON AND INSULIN FLOW BLOCK. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. TROUBLESHOOTING WAS PERFORMED. THE DEVICE WILL BE RETURNED FOR ANALYSIS. THE CUSTOMER WILL DISCONTINUE TO USE OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2910083 630G INSULIN PUMP MMT-1715KL 630G ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1715KL HG4JW86 000000763000316655

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female