BEUDAMED
    FDA Adverse Event Death Summary report: N

    640G INSULIN PUMP MMT-1711K

    MDR report key: 15039794 · Received July 18, 2022

    Report

    Report Number
    2032227-2022-289371
    Event Type
    Death
    Date Received
    July 18, 2022
    Date of Event
    August 20, 2019
    Report Date
    July 18, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    00643169554931
    Removal / Correction Number
    Z-0958-2020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS PART OF A RETROSPECTIVE REVIEW AND REMEDIATION EFFORTS IN RESPONSE TO A WARNING LETTER. CORRECTION/REMOVAL NUMBER: Z-0958-2020. (B)(4). S/W 2.6D. THE UNIT DID NOT HAVE A BATTERY INSTALLED WHEN RECEIVED. UNIT PASSED THE SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST AND THE DAT TEST AT 0.08720 INCHES. PUMP ERROR 63 (VARIABLE 3) ALARMED DURING SELF TEST DUE TO BROKEN TRACE AT U1 PIN 6 (SDA) ON KEYPAD ASSEMBLY. TOGGLED ON/OFF AND INCREASED/DECREASED VOLUME WITH THE AUDIO FEATURE FUNCTIONING PROPERLY. NO AUDIO/VIBRATE/ABSENCE OF ALARM ANOMALIES NOTED DURING TESTING. UNIT UPLOADED PROPERLY USING CARELINK. UNIT HAD MINOR SCRATCHED DISPLAY WINDOW, MISSING DISPLAY WINDOW COVER, SCRATCHED CASE, CRACKED BATTERY TUBE THREADS, CRACKED CASE AT THE CORNER OF THE BELT CLIP RAIL, STAINED/PEELING SERIAL NUMBER LABEL, PILLOWING KEYPAD OVERLAY, CRACKED KEYPAD OVERLAY AT THE SELECT BUTTON AND A CRACKED RETAINER. DATA ANALYSIS: (THE DATE OF DEATH WAS NOT SPECIFIED IN THE CUSTOMER NOTES.) THE FORMATTED HISTORY FILE LISTS DATA FROM (B)(6) 2016 TO (B)(6) 2019. 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

    IT WAS REPORTED VIA PHONE CALL THAT THE CUSTOMER PASSED AWAY. THE CAUSE OF DEATH WAS CANCER. THE CALLER STATED THAT THEY DID NOT WANTED TO PROVIDE INFORMATION ABOUT CUSTOMER'S DEATH. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF DEATH. IT WAS UNKNOWN IF THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. IT WAS UNKNOWN IF THE CUSTOMER WAS USING SENSORS AT THE TIME OF DEATH. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS. FRN-UNK-RSVR, UNOMED INF SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1112238 640G INSULIN PUMP MMT-1711K PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1711K 00643169554931

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death