BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 14692976 · Received June 15, 2022

    Report

    Report Number
    2032227-2022-213475
    Event Type
    Death
    Date Received
    June 15, 2022
    Date of Event
    January 1, 2022
    Report Date
    June 15, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000190460
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER PASSED AWAY ON (B)(6) 2022. 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 0.0875 INCHES. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: MINOR SCRATCHED DISPLAY WINDOW, SCRATCHED CASE, PILLOWING KEYPAD OVERLAY, CRACKED KEYPAD OVERLAY AT THE SELECT BUTTON 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 (B)(6) 2021 LISTED ON SMARTSOLVE AND THE DAYS PRIOR TO THAT DATE. THERE WAS NO DATA LISTED ON (B)(6) 2022. 12/25/2021 DAILY TOTAL OF ALL INSULIN DELIVERED: 0, 12/26/2021 DAILY TOTAL OF ALL INSULIN DELIVERED: 0, 12/27/2021 DAILY TOTAL OF ALL INSULIN DELIVERED: 0, 12/28/2021 DAILY TOTAL OF ALL INSULIN DELIVERED: 0, 12/29/2021 DAILY TOTAL OF ALL INSULIN DELIVERED: 0, 12/30/2021 DAILY TOTAL OF ALL INSULIN DELIVERED: 0, 12/31/2021 DAILY TOTAL OF ALL INSULIN DELIVERED: 0. THE PUMP PASSED THE FUNCTIONAL TESTING.

    Description of Event or Problem · 0

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT CUSTOMER WAS PASSED AWAY. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1847568 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG3MM2T 000000763000190460

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Death