BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 13589708 · Received February 24, 2022

    Report

    Report Number
    2032227-2022-117695
    Event Type
    Malfunction
    Date Received
    February 24, 2022
    Date of Event
    February 19, 2022
    Report Date
    September 11, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    000000763000367039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KU
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. 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

    PUMP PASSED DISPLACEMENT TEST, SELF TEST, ACTIVE CURRENT MEASUREMENT AND SLEEP CURRENT MEASUREMENT. PUMP SUCCESSFULLY DOWNLOADED TO THUS. THE POWER MANAGEMENT GRAPH CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WERE WITHIN SPEC RANGE. NO PUMP ERROR 23, PUMP ERROR 49, PUMP ERROR 68 OR STUCK BUTTON ALARM NOTED DURING TEST. CONFIRMED THE IN THE PUMP DOWNLOADED HISTORY THE PUMP ALARMED PUMP ERROR 23 ON (B)(6) 2022 19:29:34.000, PUMP ERROR 49 ON (B)(6) 2022 19:29:26.000 AND PUMP ERROR 68 ON (B)(6) 2022 19:18:00.000 DUE TO MOISTURE DAMAGE TO THE PCB1 BOARD AND PCB2 BOARD. INTERMITTENT RESPONSE FROM ALL BUTTONS DUE TO MOISTURE DAMAGE TO KEYPAD TRACES. VERIFIED PUMP ALARMED STUCK BUTTON ON (B)(6) 2022 18:51:00.000 IN PUMP DOWNLOADED HISTORY. UNIT PASSED THE KEYPAD VOLTAGE TEST. THE J1 CONNECTOR ON PCB1 WAS LOCKED PROPERLY DURING VISUAL INSPECTION. FOUND MOISTURE DAMAGE TO MOTOR ASSEMBLY, PCB1 BOARD AND PCB2 BOARD DURING VISUAL INSPECTION. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: CORRODED ELECTRONIC ASSEMBLIES, CORRODED BATTERY TUBE, CORRODED MOTOR HOME SWITCH, SCRATCHED CASE, PILLOWING KEYPAD OVERLAY AND CRACKED CASE CORNER OF THE BELT CLIP RAILS NEAR THE BATTERY COMPARTMENT, THE P-CAP/RESERVOIR DOES LOCK PROPERLY. NO PUMP ERROR 23, PUMP ERROR 49, PUMP ERROR 68 OR STUCK BUTTON ALARM NOTED DURING TEST. CONFIRMED THE IN THE PUMP DOWNLOADED HISTORY THE PUMP ALARMED PUMP ERROR 23 ON (B)(6) 2022 19:29:34.000, PUMP ERROR 49 ON (B)(6) 2022 19:29:26.000 AND PUMP ERROR 68 ON (B)(6) 2022 19:18:00.000 DUE TO MOISTURE DAMAGE TO THE PCB1 BOARD AND PCB2 BOARD. CONFIRMED PUMP ALARMED STUCK BUTTON ON (B)(6) 2022 18:51:00.000 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 KEYPAD ANOMALY. CUSTOMER STATED INSULIN PUMP HAD MULTIPLE INSULIN PUMP ERROR ALARM AND WERE ABLE TO CLEAR THE ALARMS. CUSTOMER STATED THAT WHEN THEY RESTARTED THE INSULIN PUMP THE BUTTONS WERE NOT RESPONDING. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED, TROUBLESHOOTING WAS SUCCESSFULLY PERFORMED AND CUSTOMER WILL DISCONTINUE THE USE OF DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2049570 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 HG4Z24J 000000763000367039

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown