BEUDAMED
    FDA Adverse Event Death Summary report: N

    640G INSULIN PUMP MMT-1712K

    MDR report key: 15038502 · Received July 18, 2022

    Report

    Report Number
    2032227-2022-288835
    Event Type
    Death
    Date Received
    July 18, 2022
    Date of Event
    June 25, 2018
    Report Date
    July 17, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    00643169739512
    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. Z-0958-2020. (B)(4). SOFTWARE VERSION 2.9D. INSULIN PUMP RECEIVED WITH AN ENERGIZER ALKALINE BATTERY INSTALLED. 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 DAT TEST AT 0.08735 INCHES. INSULIN PUMP HAD SCRATCHED CASE, CRACKED BATTERY TUBE THREADS, CRACKED CASE AT BATTERY TUBE SIDE, PILLOWING KEYPAD OVERLAY AND CRACKED RETAINER. DATA ANALYSIS: (DATE OF DEATH 25 JUNE 2018.) (B)(6) 2018 DAILY TOTAL OF ALL INSULIN DELIVERED = 20.7. (B)(6) 2018 DAILY TOTAL OF ALL INSULIN DELIVERED = 29.075. (B)(6) 2018 DAILY TOTAL OF ALL INSULIN DELIVERED = 26.3. (B)(6) 2018 DAILY TOTAL OF ALL INSULIN DELIVERED = 36.8. (B)(6) 2018 DAILY TOTAL OF ALL INSULIN DELIVERED = 31.175 .(B)(6) 2018 DAILY TOTAL OF ALL INSULIN DELIVERED = 15.9 (B)(6) 2018 DAILY TOTAL OF ALL INSULIN DELIVERED = 263.35. 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 AT HOME. THE CAUSE OF DEATH WAS SUICIDE BY INTENTIONAL INSULIN OVER DOSE WITH THE PUMP. THE CALLER STATED THAT THE CUSTOMER WAS FOUND AFTER BEING UNACCOUNTED FOR 24 HOURS. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF DEATH. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE PUMP HISTORY REVEALED THAT THE CUSTOMER ADMINISTERED SEVERAL BOLUSES FOR A TOTAL OF 105 UNITS AND SET THEIR BASAL RATE TO 35 UNITS PER HOUR. IT IS UNKNOWN IF THE CUSTOMER WAS USING SENSORS. NO FURTHER INFORMATION WAS PROVIDED DUE TO PRIVACY LAWS. IT IS UNKNOWN IF THE CALLER AGREED TO RETURN THE INSULIN PUMP FOR ANALYSIS. THE PUMP PASSED FUNCTIONAL TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1057676 640G INSULIN PUMP MMT-1712K PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1712K 00643169739512

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death