BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    640G INSULIN PUMP MMT-1712K

    MDR report key: 12172301 · Received July 15, 2021

    Report

    Report Number
    2032227-2021-167946
    Event Type
    Malfunction
    Date Received
    July 15, 2021
    Date of Event
    July 7, 2021
    Report Date
    March 24, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    000000643169739512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINER = CLEAR. CUSTOMER RETURNED DEVICE FOR AN ALLEGED CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM AND MOISTURE DAMAGE FOUND ON (B)(6) 2021. THE PUMP POWERED UP PROPERLY AFTER BATTERY INSTALLATION. NO CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM NOTED. THE DEVICE PASSED THE SELF TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, AND THE DISPLACEMENT TEST. SUCCESSFULLY DOWNLOADED THE TRACE/HISTORY FILES USING THUS. A REVIEW OF THE TRACE/HISTORY DOWNLOAD REVEAL NO FATAL ALARMS OR MULTIPLE CRITICAL ERROR HANDLING ALARMS THAT WOULD CAUSE CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM HOWEVER, ON (B)(6) 2021 AT 14:05 THERE WAS ONE PUMP ERROR 3 (LINE NUMBER 2723 FILE NUMBER 124) ALARM OCCURRED. THE DEVICE WAS CUT OPEN FOR VISUAL INSPECTION. NO DAMAGE OR MOISTURE DAMAGE ON ELECTRICAL BOARD 2, THE MOTOR, OR THE FORCE SENSOR HOWEVER, MOISTURE DAMAGE WAS FOUND ON ELECTRICAL BOARD 1. THE FORCE SENSOR ZERO OFFSET IS WITHIN SPECIFICATION (23.6 MV). PUMP ERROR 3 (LINE NUMBER 2723 FILE NUMBER 124) ALARM IS DUE TO MOISTURE DAMAGE ON ELECTRICAL BOARD 1. A TEST P-CAP DOES LOCK INTO PLACE INSIDE THE RESERVOIR COMPARTMENT PROPERLY. THE FOLLOWING WERE NOTED DURING PHYSICAL INSPECTION: SCRATCHED CASE, CRACKED SELECT BUTTON KEYPAD OVERLAY, STAINED KEYPAD OVERLAY, SERIAL NUMBER LABEL FADING AND STAINED, END CAP ADDRESS LABEL FADED, PILLOWING KEYPAD OVERLAY, BATTERY COMPARTMENT CRACKED AT THE CORNER OF THE BELT CLIP RAILS, AND CRACKED BATTERY TUBE THREADS. CRITICAL PUMP ERROR (OPEN BOOK) ALARM IS NOT CONFIRMED. MOISTURE DAMAGE IS CONFIRMED. INSULIN PUMP ERROR 3 (LINE NUMBER 2723 FILE NUMBER 124) ALARM IS DUE TO MOISTURE DAMAGE ON ELECTRICAL BOARD 1. 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. 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.

    Description of Event or Problem · 1

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD CRITICAL PUMP ERROR ALARM AND SAW A RED CROSS ON SCREEN. CUSTOMER STATED THAT INSULIN PUMP WAS EXPOSED TO MOISTURE. 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
    1075469 640G INSULIN PUMP MMT-1712K PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1712K HG1VELW 000000643169739512

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown