BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    670G INSULIN PUMP MMT-1780KL

    MDR report key: 12961121 · Received December 8, 2021

    Report

    Report Number
    2032227-2021-228190
    Event Type
    Malfunction
    Date Received
    December 8, 2021
    Date of Event
    November 29, 2021
    Report Date
    May 24, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000283513
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINER RING=BLACK CUSTOMER COMPLAINED ON 11/29/20201 THE DEVICE ALARMED INSULIN FLOW BLOCKED AND ABNORMAL MOTOR NOISE. COMPLAINED THE BUTTONS ARE NOT RESPONDING PROPERLY AND THE DISPLAY IS SCRATCHED. DEVICE PASSED THE SELF TEST, DISPLACEMENT TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST AND OCCLUSION TEST. NO ABNORMAL MOTOR NOISE OR UNEXPECTED INSULIN FLOW BLOCKED ALARMS NOTED DURING TESTING. DEVICE SUCCESSFULLY DOWNLOADED TO THUS. CONFIRMED PUMP ALARMED INSULIN FLOW BLOCKED ALARM ON 11/22/2021 22:57:19.000 IN PUMP DOWNLOADED HISTORY. MOTOR WAS TESTED OUTSIDE OF THE DEVICE AND PASSED. INTERMITTENT RESPONSE FROM ALL BUTTONS DUE TO MOISTURE DAMAGE TO KEYPAD TRACES. DEVICE PASSED THE KEYPAD VOLTAGE TEST. THE J1 CONNECTOR ON PCB1 WAS LOCKED PROPERLY DURING VISUAL INSPECTION. THE ELECTRONIC ASSEMBLIES WERE INSPECTED AND NO ANOMALIES NOTED. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: SCRATCHED CASE, PILLOWING KEYPAD OVERLAY, END CAP ADDRESS LABEL MISSING AND SCRATCHED LCD WINDOW. THE P-CAP/RESERVOIR DOES LOCK PROPERLY. CONFIRMED INTERMITTENT RESPONSE FROM ALL BUTTONS DUE TO MOISTURE DAMAGE TO KEYPAD TRACES. NO ABNORMAL MOTOR NOISE OR UNEXPECTED INSULIN FLOW BLOCKED ALARMS NOTED DURING TESTING. CONFIRMED PUMP ALARMED INSULIN FLOW BLOCKED ALARM ON 11/22/2021 22:57:19.000 IN PUMP DOWNLOADED HISTORY. CONFIRMED SCRATCHED LCD WINDOW. THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5. 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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 0

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP ENTER BUTTON WAS WORKING INTERMITTENTLY. IT WAS REPORTED THAT INSULIN PUMP SCREEN WAS SCUFFED REDUCING VISIBILITY TO READ THE MENUS, MOTOR WAS LOUDER THAN USUAL AND RECEIVED NO DELIVERY ALERTS. CUSTOMER WAS ABLE TO READ THE SCREEN. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1863507 670G INSULIN PUMP MMT-1780KL ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KL HG4CMSR 000000763000283513

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Male