BEUDAMED
    FDA Adverse Event Injury Summary report: N

    640G INSULIN PUMP MMT-1711K

    MDR report key: 10834943 · Received November 13, 2020

    Report

    Report Number
    2032227-2020-205370
    Event Type
    Injury
    Date Received
    November 13, 2020
    Date of Event
    July 20, 2020
    Report Date
    May 3, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    00643169739468
    Removal / Correction Number
    Z-0958-2020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BA
    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

    UNIT PASSED THE SELF TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST AND FORCE SENSOR TEST. UNABLE TO PERFORM THE DISPLACEMENT TEST, OCCLUSION TEST AND DAT TEST DUE TO MISSING RETAINER. THE TEST P-CAP AND RESERVOIR WILL NOT LOCK IN PLACE IN THE RESERVOIR COMPARTMENT DUE TO MISSING RETAINER. NO POST-RESET RAM CRC ALARM NOTED DURING TESTING. UNIT WAS ALSO MONITORED FOR 3 DAYS. NO POST-RESET RAM CRC ALARM NOTED. UNIT UPLOADED PROPERLY USING CARELINK. UNIT ALSO HAD A MISSING RESERVOIR TUBE O-RING, BROKEN RESERVOIR TUBE LIP, MISSING DISPLAY WINDOW COVER, SCRATCHED CASE, BROKEN BATTERY TUBE THREADS, CRACKED CASE AT BATTERY TUBE SIDE, KEYPAD OVERLAY TEXTURE DAMAGE, STAINED KEYPAD OVERLAY, PILLOWING KEYPAD OVERLAY AND CRACKED KEYPAD OVERLAY AT THE SELECT BUTTON. (B)(4). 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

    ADDITIONAL INFORMATION HAS BEEN RECEIVED WHICH WAS NOT INCLUDED WITH THE INITIAL REPORT. THE INFORMATION HAS BEEN PROVIDED WITH THIS REPORT.

    Description of Event or Problem · 1

    INFORMATION RECEIVED BY MEDTRONIC INDICATES THE CUSTOMER WENT TO THE HOSPITAL DUE TO HIGH BLOOD GLUCOSE READINGS AND THE PRESENCE OF KETONES. THE CUSTOMER CORRECTED THE BLOOD GLUCOSE BY CHANGING THE RESERVOIR AND USING THE PUMP. THE CUSTOMER CHECKED THEIR ALARM HISTORY AND POST-RESET RAM CRC ALARM WAS FOUND ONE TIME AFTER CHANGING THE BATTERY. THE CUSTOMER CONFIRMED THE INSULIN PUMP WAS WITHOUT A BATTERY FOR AN EXTENDED PERIOD OF TIME AND THE PUMP HAD BEEN DROPPED PREVIOUSLY. IT WAS CONFIRMED THAT THE RESERVOIR WAS ABLE TO LOCK INTO PLACE. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    THE O-RING WAS DISLOCATED FROM THE INSULIN PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1302310 640G INSULIN PUMP MMT-1711K PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1711K HG1QML6 00643169739468

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown