BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    670G INSULIN PUMP MMT-1780KL

    MDR report key: 15415947 · Received September 14, 2022

    Report

    Report Number
    2032227-2022-334768
    Event Type
    Malfunction
    Date Received
    September 14, 2022
    Date of Event
    May 19, 2022
    Report Date
    September 14, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000365882
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). RETAINER RING = BLACK THE DEVICE WAS RETURNED FOR THIS ALARM IS GENERATED WHEN THE PUMP DETECTS MOVEMENT IN HALL SENSOR COUNTS THAT ARE UNEXPECTED SINCE THE PUMP DID NOT COMMAND MOTOR MOVEMENT ALARM FOUND ON (B)(4), 2022. DEVICE PASSED THE SELF-TEST, DISPLACEMENT TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST AND OCCLUSION TEST. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. NO UNEXPECTED THIS ALARM IS GENERATED WHEN THE PUMP DETECTS MOVEMENT IN HALL SENSOR COUNTS THAT ARE UNEXPECTED SINCE THE PUMP DID NOT COMMAND MOTOR MOVEMENT ALARM NOTED DURING TESTING. DEVICE SUCCESSFULLY DOWNLOADED TO THUS. THIS ALARM IS GENERATED WHEN THE PUMP DETECTS MOVEMENT IN HALL SENSOR COUNTS THAT ARE UNEXPECTED SINCE THE PUMP DID NOT COMMAND MOTOR MOVEMENT ALARM CONFIRMED IN THE DEVICE HISTORY/TRACE FILES ON MAY 19, 2022 15:16:02 AND MAY 19, 2022 10:36:16. DEVICE WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND¿NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE¿ON THE ELECTRONIC ASSEMBLY, OR FORCE SENSOR. FORCE SENSOR WAS MEASURED AND IS WITHIN SPEC (22.3MV AT ZERO OFFSET). MOTOR WAS TESTED OUTSIDE OF THE DEVICE USING THE NGP SYSTEM BOARD TEST AND PASSED. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: SCRATCHED CASE, PILLOWING KEYPAD OVERLAY, CRACKED CASE, CRACKED CASE (BATTERY TUBE), CRACKED CASE-CORNER OF BELT CLIP RAILS, BATTERY TUBE THREADS - CRACKED, AND LABEL DAMAGE. THIS ALARM IS GENERATED WHEN THE PUMP DETECTS MOVEMENT IN HALL SENSOR COUNTS THAT ARE UNEXPECTED SINCE THE PUMP DID NOT COMMAND MOTOR MOVEMENT ALARM NOT CONFIRMED DURING TESTING, HOWEVER WAS FOUND IN THE DEVICE HISTORY/TRACE FILES ON MAY 19, 2022 15:16:02 AND MAY 19, 2022 10:36:16, PROBLEM ISOLATED TO THE MOTOR. 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 STATED THAT THE INSULIN PUMP HAD A PUMP ERROR ALARM. CUSTOMER STATED THAT THEY WERE ABLE TO CLEAR AND ABLE TO REWIND THE PUMP. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE USE OF THE DEVISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2740538 670G INSULIN PUMP MMT-1780KL ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KL HG4ECZD 000000763000365882

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male