BEUDAMED
    FDA Adverse Event Death Summary report: N

    640G INSULIN PUMP MMT-1712K

    MDR report key: 15037896 · Received July 18, 2022

    Report

    Report Number
    2032227-2022-288879
    Event Type
    Death
    Date Received
    July 18, 2022
    Date of Event
    June 5, 2019
    Report Date
    July 17, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    00763000192143
    Removal / Correction Number
    Z-0958-2020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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). SOFTWARE VERSION 4.11D. THE INSULIN PUMP DID NOT HAVE A BATTERY INSTALLED WHEN RECEIVED. INSULIN PUMP PASSED THE FUNCTIONAL TEST, 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 THE DELIVERY ACCURACY TEST TEST AT 0.08690 INCHES. INSULIN PUMP UPLOADED PROPERLY USING CARELINK. INSULIN PUMP HAD MINOR SCRATCHED DISPLAY WINDOW, SCRATCHED DISPLAY WINDOW COVER, SCRATCHED CASE, SCRATCHED KEYPAD OVERLAY, PILLOWING KEYPAD OVERLAY AND CRACKED RETAINER. DATA ANALYSIS: (THE DATE OF DEATH WAS NOT SPECIFIED IN THE CUSTOMER NOTES.) THE FORMATTED HISTORY FILE LISTS DATA FROM (B)(6) 2018 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

    (B)(6) 2019 17:26:48 PST ICE BATCH USER (BATCH_ICE) PHONE (B)(6). COMPLAINT: (B)(4). COMPLAINT STATUS: IN PROCESS MDT INITIAL CONTACT: (B)(6). TAKEN BY: (B)(6). CUSTOMER DIED OF HEART ATTACK. COUNTRY: GERMANY. CITY: DUISBURG. ZIP: (B)(6). INPUT DATE: 06/05/2019 WARRANTY START: 00/00/0000 WARRANTY END: 00/00/0000 BATCH - NG1789566H.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2893804 640G INSULIN PUMP MMT-1712K PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1712K 00763000192143

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death