BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    670G INSULIN PUMP MMT-1780KL

    MDR report key: 15122747 · Received July 28, 2022

    Report

    Report Number
    2032227-2022-304323
    Event Type
    Malfunction
    Date Received
    July 28, 2022
    Date of Event
    January 24, 2022
    Report Date
    July 28, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000283513
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). SOFTWARE VERSION 4.11E. RETAINER RING=BLACK. CUSTOMER COMPLAINED ON (B)(6) 2022 THE INSULIN PUMP ALARMED PUMP ERROR 3 AND PUMP ERROR 54. DEVICE PASSED THE SELF TEST AND DISPLACEMENT TEST. NO PUMP ERROR 3 OR PUMP ERROR 54 NOTED DURING TESTING. DEVICE SUCCESSFULLY DOWNLOAD TO THUS. HOWEVER, THE FORMATTED HISTORY FILE CONFIRMED THE INSULIN PUMP ALARMED PUMP ERROR 3 ON (B)(6) 202213:58:37.000 AND PUMP ERROR 54 (LINE NUMBER 1421 FILE NUMBER 32122) ON (B)(6) 2022 13:58:35.000 DUE TO SOFTWARE ERROR. 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 MOTOR HOME SWITCH, SCRATCHED CASE, PILLOWING KEYPAD OVERLAY, CRACKED BATTERY TUBE THREADS AND CRACKED CASE CORNER OF THE BELT CLIP RAILS NEAR THE BATTERY COMPARTMENT, THE P-CAP/RESERVOIR DOES LOCK PROPERLY. NO PUMP ERROR 3 OR PUMP ERROR 54 NOTED DURING TESTING. HOWEVER, CONFIRMED THE PUMP ALARMED PUMP ERROR 3 AND PUMP ERROR 54 DUE TO SOFTWARE ERROR. 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 THAT THEY WERE ABLE TO CLEAR AND REWIND THE INSULIN PUMP AND PASSED IN SELF TEST. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2333819 670G INSULIN PUMP MMT-1780KL ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KL HG5M421 000000763000283513

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female