BEUDAMED
    FDA Adverse Event Death Summary report: N

    630G INSULIN PUMP MMT-1715KL 630G

    MDR report key: 14730689 · Received June 17, 2022

    Report

    Report Number
    2032227-2022-214925
    Event Type
    Death
    Date Received
    June 17, 2022
    Date of Event
    October 12, 2021
    Report Date
    June 17, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    000000763000166519
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). S.W VERSION 4.10C. RETAINER RING = CLEAR. THE CUSTOMER PASSED AWAY ON (B)(6) 2021. THE PUMP PASSED THE FUNCTIONAL TESTS, 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 DAT AT 0.08710 INCHES. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUS. SUCCESSFULLY UPLOADED PUMP TO CARELINK. THE TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT. HOWEVER, A CRACKED RETAINER WAS NOTED DURING TESTING. THE FOLLOWING WERE ALSO NOTED DURING VISUAL INSPECTION: A PILLOWING KEYPAD OVERLAY, A SCRATCHED CASE AND A SERIAL NUMBER LABEL FADING. THE PUMP WAS RECEIVED WITHOUT A BATTERY INSTALLED. PLEASE SEE BELOW FOR THE DATE RANGE LISTED IN THE FORMATTED HISTORY FILE. THE FORMATTED HISTORY FILE LISTS DATA FROM 01/01/2009, 10/23/2019 TO 09/10/2021. A CRACKED RETAINER WAS CONFIRMED. THE PUMP PASSED ALL THE REQUIRED TESTING. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE 640G INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA PHONE CALL THAT THE CUSTOMER PASSED AWAY. NO FURTHER INFORMATION WAS GIVEN DUE TO DATA PROTECTION. THE CALLER RETURNED THE INSULIN PUMP FOR ANALYSIS. THE CASE IS REPORTED ONLY FOR THE F.A RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162577 630G INSULIN PUMP MMT-1715KL 630G ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1715KL HG3RN0M 000000763000166519

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Death