BEUDAMED
    FDA Adverse Event Death Summary report: N

    640G INSULIN PUMP MMT-1711K

    MDR report key: 15049277 · Received July 19, 2022

    Report

    Report Number
    2032227-2022-291717
    Event Type
    Death
    Date Received
    July 19, 2022
    Date of Event
    July 17, 2017
    Report Date
    July 18, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    00643169662568
    Removal / Correction Number
    Z-0958-2020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS PART OF A RETROSPECTIVE REVIEW AND REMEDIATION EFFORTS IN RESPONSE TO A WARNING LETTER. CORRECTION/REMOVAL REPORTING NUMBER: Z-0958-2020. (B)(4). PUMP RECEIVED NOT STUCK IN THE MANUFACTURING MODE. SW 2.9D. PUMP PASSED THE FUNCTIONAL TESTS, INCLUDING THE SELF TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST AND DAT AT 0.08695 INCHES. PUMP RECEIVED WITH ENERGIZER INDUSTRIAL ALKALINE BATTERY PUMP RECEIVED WITH CRACKED RETAINER, SCRATCHED CASE, PILLOWING KEYPAD OVERLAY, SCRATCHED KEYPAD OVERLAY AND MINOR SCRATCHED LCD WINDOW. DATA ANALYSIS: (B)(6) 2017 DAILY TOTAL OF ALL INSULIN DELIVERED = 17.9; (B)(6) 2017 DAILY TOTAL OF ALL INSULIN DELIVERED = 10.9; (B)(6) 2017 DAILY TOTAL OF ALL INSULIN DELIVERED = 19.85; (B)(6) 2017 DAILY TOTAL OF ALL INSULIN DELIVERED = 16.9; (B)(6) 2017 DAILY TOTAL OF ALL INSULIN DELIVERED = 16.9; (B)(6) 2017 DAILY TOTAL OF ALL INSULIN DELIVERED = 16.9; (B)(6) 2017 DAILY TOTAL OF ALL INSULIN DELIVERED = 12.35. 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 THAT THE CUSTOMER PASSED AWAY IN HOSPITAL. THE CUSTOMER WAS HOSPITALIZED ON (B)(6) 2017 DUE TO BEING UNRESPONSIVE. THE CAUSE OF DEATH WAS STILL UNKNOWN AS THE POST MORTEM WAS PENDING. THE CALLER STATED THAT THE CUSTOMER HAD NO ILLNESSES THAT MAY HAVE LED TO THE CUSTOMER'S PASSING. THE CUSTOMER¿S BLOOD GLUCOSE WAS 83 MG/DL TWO DAYS BEFORE THE TIME OF DEATH. IT IS UNKNOWN IF THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE PUMP HAD A BATTERY FAILURE ALARM AND THE SCREEN HAD A PARTIAL DISPLAY. IT IS UNKNOWN IF THE CUSTOMER WAS USING SENSORS. THE CALLER AGREED TO RETURN THE INSULIN PUMP FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1718186 640G INSULIN PUMP MMT-1711K PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1711K HG0SPCX 00643169662568

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| D