BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    670G INSULIN PUMP MMT-1780KL

    MDR report key: 15398922 · Received September 12, 2022

    Report

    Report Number
    2032227-2022-331071
    Event Type
    Malfunction
    Date Received
    September 12, 2022
    Date of Event
    August 29, 2022
    Report Date
    November 24, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000283513
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    RETAINER RING = BLACK. CUSTOMER RETURNED INSULIN PUMP FOR AN ALLEGED INSULIN PUMP ERROR ALARM FOUND ON (B)(6), 2022. THE INSULIN PUMP PASSED THE FUNCTIONAL TESTS, INCLUDING THE SELF TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST AND DELIVERY ACCURACY TEST ALARM NOTED DURING THE TESTING. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUS. INSULIN PUMP ERROR ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE FOR THE EVENT DATE. (B)(6), 2022 08:00:22.000, (B)(6), 2022 08:00:27.000, (B)(6), 2022 08:04:21.000, (B)(6), 2022 08:05:03.000, (B)(6), 2022 08:06:03.000, (B)(6), 2022 08:07:03.000 (B)(6), 2022 08:10:03.000, (B)(6), 2022 08:10:18.000, (B)(6), 2022 08:13:27.000, (B)(6), 2022 08:19:25.000 AND (B)(6), 2022 08:24:13.000. INSULIN PUMP ERROR ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE FOR THE EVENT DATE. (B)(6), 2022 08:04:34.000 NO INSULIN PUMP ERROR ALARM RECORDED IN THE FORMATTED HISTORY FILE FOR THE EVENT DATE. INSULIN PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND CORROSION ON THE ELECTRICAL BOARD FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. CORROSION WAS ALSO FOUND ON THE BATTERY TUBE ASSEMBLY NOTED. INSULIN PUMP ERROR ALARM AND INSULIN PUMP ERROR ALARM WERE CONFIRMED ACCORDING IN THE FORMATTED HISTORY FILE DOWNLOAD DUE TO CORROSION ON THE ELECTRICAL BOARD AND MOTOR ASSEMBLY NOTED. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A CRACKED BATTERY TUBE THREADS, A SCRATCHED CASE AND A CRACKED CASE-CORNER OF BELT CLIP RAILS NEAR THE BATTERY TUBE COMPARTMENT. INSULIN PUMP ERROR ALARM AND INSULIN PUMP ERROR ALARM WERE CONFIRMED. INSULIN PUMP ERROR ALARM AND PUMP ERROR ALARM ACCORDING IN THE FORMATTED HISTORY FILE DOWNLOAD DUE TO CORROSION ON THE ELECTRICAL BOARD AND MOTOR ASSEMBLY NOTED. DURING VISUAL INSPECTION, CORROSION WAS FOUND ON THE FORCE SENSOR AND VIBRATOR¿ASSEMBLY NOTED. CORROSION WAS ALSO FOUND ON THE BATTERY TUBE ASSEMBLY NOTED. 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 INSULIN PUMP HAD PUMP ERROR THIS ALARM IS GENERATED WHEN THE PUMP DETECTS MOVEMENT IN HALL SENSOR COUNTS THAT ARE UNEXPECTED SINCE THE PUMP DID NOT COMMAND MOTOR MOVEMENT. CUSTOMER REPORTED THEY WERE ABLE TO CLEAR THE ALARM. CUSTOMER STATED THEY WERE UNABLE TO REWIND THE INSULIN PUMP. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE TO USE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1360339 670G INSULIN PUMP MMT-1780KL ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KL HG5DWCC 000000763000283513

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Male