BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMP MMT-1715KM 630G 3ML BLACK MEDI  

    MDR report key: 12717326 · Received October 29, 2021

    Report

    Report Number
    2032227-2021-211943
    Event Type
    Death
    Date Received
    October 29, 2021
    Date of Event
    September 13, 2021
    Report Date
    March 23, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    000000643169873834
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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. INFORMATION HAS BEEN CORRECTED WHICH WAS NOT CORRECT IN THE INITIAL REPORT. THE INFORMATION HAS BEEN PROVIDED IN SECTION B3 WITH THIS REPORT TO CORRECT EVENT DATE AND SECTION B5 WAS CLARIFIED.

    Additional Manufacturer Narrative · 0

    THE INFORMATION RELATED TO EVENT HAS BEEN UPDATED IN SUMMARY AND PROVIDED IN THIS REPORT.

    Description of Event or Problem · 0

    THE CUSTOMER¿S SPOUSE CALLED AND INDICATED THAT THEY RECEIVED A LETTER REGARDING A DEVICE RECALL. THE CALLER STATED THAT THE LETTER WAS ADDRESSED TO THE CUSTOMER WHO PASSED AWAY ON (B)(6) 2021. IT WAS ALSO INDICATED THAT THE PRODUCTS CANNOT BE RETURNED FOR DESTRUCTIVE ANALYSIS DUE TO THE PUMP AND ALL SUPPLIES AND METERS HAVE BEEN THROWN AWAY. NO DEVICE ISSUE RELATED TO A RECALL WAS MENTIONED.

    Description of Event or Problem · 0

    THIS CASE IS TO DOCUMENT THE LOW ON (B)(6) 2021. PLEASE SEE (B)(4) FOR THE DOCUMENTATION OF THE PASSING ON (B)(6) 2021. CUSTOMER WAS NOT HOSPITALIZED. CUSTOMER'S WIFE REPORTED THAT CUSTOMER'S SUGARS DIPPED TOO LOW AND THAT LED TO CUSTOMER'S PASSING ON (B)(6) 2021 IN THE AFTERNOON. CUSTOMER WAS NOT FEELING GOOD. CUSTOMER HAD TAKEN THE PUMP OFF AT 9PM ON (B)(6) 2021 SO HE COULD SLEEP AND NOT HAVE TO WORRY ABOUT GOING LOW. IT IS UNKNOWN IF PUMP WAS USED AT THE TIME OF THE LOW BLOOD GLUCOSE ON (B)(6) 2021. CALLER WAS UNSURE IF CUSTOMER WAS ON CONTINUOUS GLUCOSE MONITORING FOR HIS DIABETES THERAPY. PUMP DOES NOT HAVE AUTO MODE FEATURE.

    Additional Manufacturer Narrative · 1

    (B)(4). CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA PHONE CALL THAT THE CUSTOMER PASSED AWAY AT HOME. THE CUSTOMER WAS HOSPITALIZED ON (B)(6) 2021 DUE TO LOW BLOOD GLUCOSE. THE CAUSE OF DEATH WAS LOW BLOOD GLUCOSE OF 16 MG/DL. THE CALLER STATED THAT THE CUSTOMER HAD LOW BLOOD GLUCOSE THAT MAY HAD LED TO THE CUSTOMER'S PASSING. THE CUSTOMER¿S BLOOD GLUCOSE WAS 16 MG/DL AT THE TIME OF DEATH. THE CUSTOMER WAS NOT WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE CUSTOMER WAS NOT USING SENSORS. THE AUTO MODE ON THE INSULIN PUMP WAS NOT ACTIVE AND AUTOMATICALLY ADJUSTING INSULIN DELIVERY DURING THE EVENT. THE INSULIN PUMP HAD BEEN DISCONNECTED 24 HOURS PRIOR TO PASSING. CUSTOMER REPORTED THAT THE INSULIN PUMP WAS THROWN AWAY. THE PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1615649 PUMP MMT-1715KM 630G 3ML BLACK MEDI   ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1715KM HG1LMEJ 000000643169873834

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Death FRN-UNK-RSVR, UNOMED SET| FRN-UNK-RSVR, UNOMED SET