BEUDAMED
    FDA Adverse Event Injury Summary report: N

    640G INSULIN PUMP MMT-1712K

    MDR report key: 12007648 · Received June 16, 2021

    Report

    Report Number
    2032227-2021-157366
    Event Type
    Injury
    Date Received
    June 16, 2021
    Date of Event
    June 11, 2021
    Report Date
    December 15, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    000000763000192143
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER COMPLAINED ON (B)(6) 2021 INSULIN PUMP ALARMED STUCK BUTTON AND DAMAGED KEYPAD OVERLAY. DEVICE PASSED ACTIVE CURRENT MEASUREMENT, SLEEP CURRENT MEASUREMENT TEST, SELFTEST, REWIND, SEATING, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST AND DISPLACEMENT TEST. INTERMITTENT RESPONSE FROM ALL BUTTONS DUE TO CORRODED KEYPAD TRACES. DEVICE SUCCESSFULLY DOWNLOADED TO THUS. NO STUCK BUTTON ERROR ALARMS NOTED DURING TESTING. VERIFIED DEVICE ALARMED STUCK BUTTON ON (B)(6) 2019 22:33:45.000 IN DEVICE DOWNLOADED HISTORY. DEVICE PASSED THE KEYPAD VOLTAGE TEST. NO DAMAGE WAS NOTED TO KEYPAD ASSEMBLY AND CONNECTOR ON ELECTRICAL BOARD 1 WAS LOCKED PROPERLY DURING VISUAL INSPECTION. FOUND MOISTURE DAMAGE TO MOTOR ASSEMBLY, ELECTRICAL BOARD 1 AND ELECTRICAL BOARD 2 DURING VISUAL INSPECTION. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: CORRODED ELECTRONIC ASSEMBLIES, CORRODED BATTERY TUBE, CORRODED MOTOR HOME SWITCH, SCRATCHED CASE, PEELING KEYPAD OVERLAY, CRACKED BATTERY TUBE THREADS, MISSING DISPLAY WINDOW COVER AND CRACKED CASE CORNER OF THE BELT CLIP RAILS NEAR THE BATTERY COMPARTMENT. THE P-CAP/RESERVOIR DOES LOCK PROPERLY. DEVICE PASSED FUNCTIONAL TESTING. INTERMITTENT RESPONSE FROM ALL BUTTONS DUE TO CORRODED KEYPAD TRACES. NO STUCK BUTTON ERROR ALARMS NOTED DURING TESTING. VERIFIED DEVICE ALARMED STUCK BUTTON ON 05/18/2019 22:33:45.000 IN PUMP DOWNLOADED HISTORY. FOUND MOISTURE DAMAGE TO MOTOR ASSEMBLY, ELECTRICAL BOARD 1 AND ELECTRICAL BOARD 2 DURING VISUAL INSPECTION. CONFIRMED PEELING KEYPAD OVERLAY. 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 · 1

    (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. 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.

    Description of Event or Problem · 1

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD STUCK BUTTON ALARM. CUSTOMER HAD A LOW BLOOD GLUCOSE OF 53 MG/DL. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    909762 640G INSULIN PUMP MMT-1712K PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1712K HG34M3W 000000763000192143

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown