BEUDAMED
    FDA Adverse Event Death Summary report: N

    630G INSULIN PUMP MMT-1715K 630G BLACK MG

    MDR report key: 14741996 · Received June 20, 2022

    Report

    Report Number
    2032227-2022-216745
    Event Type
    Death
    Date Received
    June 20, 2022
    Date of Event
    October 11, 2019
    Report Date
    June 20, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    000000763000190439
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) S/W 4.11C. RETAINER RING = CLEAR. THE CUSTOMER PASSED AWAY ON (B)(6) 2019. THE CUSTOMER RECEIVED THE RECALL LETTER REGARDING RESERVOIR RETAINER RING. THE 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 AT 0.0869 INCHES. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: MINOR SCRATCHED DISPLAY WINDOW, SCRATCHED CASE, PILLOWING KEYPAD OVERLAY, AND CRACKED RETAINER. THE TEST P-CAP AND RESERVOIR DOES LOCK IN PLACE IN THE RESERVOIR COMPARTMENT. HISTORY DOWNLOAD WAS SUCCESSFUL USING THUS AND CARELINK UPLOAD WAS SUCCESSFUL. THE PUMP DID NOT HAVE A BATTERY INSTALLED WHEN RECEIVED. PLEASE SEE BELOW FOR THE CUSTOMER'S DAILY TOTAL OF ALL INSULIN DELIVERED SURROUNDING THE DATE OF (B)(6) 2019 AND THE DAYS PRIOR TO THAT DATE. THERE WAS NO DATA LISTED AFTER (B)(6) 2019. (B)(6) 2019 DAILY TOTAL OF ALL INSULIN DELIVERED = 53.2. (B)(6) 2019 DAILY TOTAL OF ALL INSULIN DELIVERED = 59.2. (B)(6) 2019 DAILY TOTAL OF ALL INSULIN DELIVERED = 45.5. (B)(6) 2019 DAILY TOTAL OF ALL INSULIN DELIVERED = 47. (B)(6) 2019 DAILY TOTAL OF ALL INSULIN DELIVERED = 25.6. (B)(6) 2019 DAILY TOTAL OF ALL INSULIN DELIVERED = 11.575. (B)(6) 2019 DAILY TOTAL OF ALL INSULIN DELIVERED = 0. THE PUMP PASSED THE FUNCTIONAL TESTING. COSMETIC DAMAGE CONFIRMED AT THE RETAINER RING (CRACKED RETAINER). 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

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT CUSTOMER PASSED AWAY ON (B)(6) 2019. CAUSE OF CUSTOMER PASSING WAS ACUTE RESPIRATORY FAILURE, PNEUMONIA. ENDO CARCINOMA AND END STAGE RENAL DISEASE. CUSTOMER DID NOT WORN INSULIN PUMP AT TIME OF PASSING. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1400296 630G INSULIN PUMP MMT-1715K 630G BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1715K HG2XVXZ 000000763000190439

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Death