BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1711KL 640G V4.10 BK SF MM

    MDR report key: 13535121 · Received February 15, 2022

    Report

    Report Number
    2032227-2022-113869
    Event Type
    Malfunction
    Date Received
    February 15, 2022
    Date of Event
    August 2, 2021
    Report Date
    February 15, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    000000763000317102
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE 640G INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES. CUSTOMER COMPLAINED ON (B)(6) 2021 THE PUMP ALARMED PUMP ERROR 53, PUMP ERROR 79, PUMP ERROR 28 AND PUMP ERROR 2. UNIT PASSED ACTIVE CURRENT MEASUREMENT, SLEEP CURRENT MEASUREMENT TEST, SELFTEST, REWIND, SEATING, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST AND DISPLACEMENT TEST. NO PUMP ERROR 53, PUMP ERROR 79, PUMP ERROR 28 OR PUMP ERROR 2 NOTED DURING TEST. UNIT SUCCESSFULLY DOWNLOADED TO THUS. NO PUMP ERROR 53 LISTED IN PUMP HISTORY DOWNLOAD. CONFIRMED IN THE PUMP HISTORY DOWNLOAD THE PUMP ALARMED PUMP ERROR 63 VARIABLE 9 ON (B)(6) 2021 16:14:51.000, PUMP ERROR 79 ON (B)(6) 2021 16:12:00.000, PUMP ERROR 28 ON (B)(6) 2021 16:12:16.000 AND PUMP ERROR 2 ON (B)(6) 2021 16:14:53.000 DUE TO FAULTY MOTOR MICROPROCESSOR U-5 ON THE PCB2 BOARD. NO MOISTURE DAMAGE NOTED ON THE MOTOR ASSEMBLY, PCB1 BOARD OR PCB 2 BOARD DURING VISUAL INSPECTION. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: SCRATCHED CASE, PILLOWING KEYPAD OVERLAY, CRACKED KEYPAD OVERLAY AND BROKEN BELT CLIP RAILS. THE P-CAP/RESERVOIR DOES LOCK PROPERLY. PUMP PASSED FUNCTIONAL TESTING. NO PUMP ERROR 53, PUMP ERROR 79, PUMP ERROR 28 OR PUMP ERROR 2 NOTED DURING TEST. HOWEVER, CONFIRMED IN THE PUMP HISTORY DOWNLOAD THE PUMP ALARMED PUMP ERROR 63 VARIABLE 9 ON (B)(6) 2021 16:14:51.000, PUMP ERROR 79 ON (B)(6) 2021 16:12:00.000, PUMP ERROR 28 ON (B)(6) 2021 16:12:16.000 AND PUMP ERROR 2 ON (B)(6) 2021 3.000 DUE TO FAULTY MOTOR MICROPROCESSOR U-5 ON THE PCB2 BOARD. NO PUMP ERROR 53 LISTED IN PUMP DOWNLOADED HISTORY. 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 MULTIPLE PUMP ERROR ALARMS. CUSTOMER STATED THEY WERE ABLE TO REWIND THE INSULIN PUMP. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1344679 PUMP MMT-1711KL 640G V4.10 BK SF MM PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1711KL 000000763000317102

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown