BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    640G INSULIN PUMP

    MDR report key: 5783401 · Received July 11, 2016

    Report

    Report Number
    3004209178-2016-60193
    Event Type
    Malfunction
    Date Received
    July 11, 2016
    Date of Event
    June 18, 2016
    Report Date
    June 1, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    Removal / Correction Number
    Z-0958-2020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS PART OF A RETROSPECTIVE REVIEW AND REMEDIATION EFFORTS IN RESPONSE TO A WARNING LETTER. UPDATED H9: Z-0958-2020. 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

    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.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH UNRESPONSIVE BUTTONS DUE TO CORRODED KEYPAD TRACES. NO STUCK BUTTON ALARMS WERE NOTED. UNABLE TO PERFORM REWIND, SEATING, BASIC OCCLUSION, OCCLUSION, FORCE SENSOR, DISPLACEMENT TEST OR VERIFY PUMP ERROR 23 AND FAILED BATTERY ALARMS DUE TO UNRESPONSIVE BUTTONS. THE INSULIN PUMP WAS RECEIVED WITH MISSING THE RETAINER RING, THE RESERVOIR TUBE O-RING AND THE DISPLAY WINDOW COVER. THE INSULIN PUMP HAD PARTIALLY BROKEN RESERVOIR TUBE LIP, CRACKED KEYPAD OVERLAY AT THE SELECT BUTTON, MINOR SCRATCHED LCD WINDOW, CASE AND KEYPAD OVERLAY.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA PHONE CALL THAT THE CUSTOMER'S INSULIN PUMP ALARMED WITH A POST-RESET ERROR ALARM, WHICH THE CUSTOMER WAS UNABLE TO CLEAR. THE PATIENT'S BLOOD GLUCOSE AT THE TIME OF INCIDENT WAS 15.0 MMOL/L. THE CUSTOMER ALSO RECEIVED A STUCK BUTTON ALARM BUT WAS UNABLE TO TROUBLESHOOT FOR THE ISSUE DUE TO THE POST-RESET ERROR ALARM. THE CUSTOMER ALSO RECEIVED A BATTERY FAILED ERROR. THEY ALSO CONFIRMED THAT THE POST-RESET ERROR OCCURRED MORE THAN ONCE AFTER A BATTERY CHANGE. THE CUSTOMER WAS ADVISED TO REVERT TO THEIR MEDICALLY PRESCRIBED BACK-UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS AND A REPLACEMENT DEVICE WAS SHIPPED TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437988 640G INSULIN PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1711B

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown