BEUDAMED
    FDA Adverse Event Death Summary report: N

    TANDEM INSULIN PUMP

    MDR report key: 21986060 · Received May 8, 2025

    Report

    Report Number
    MW5170108
    Event Type
    Death
    Date Received
    May 8, 2025
    Report Date
    May 6, 2025
    Manufacturer
    TANDEM DIABETES CARE, INC.
    Product Code
    QFG
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IN ACCORDANCE WITH 21 CFR 803.22 (B)(2), WE ARE NOTIFYING YOU THAT ON (B)(6) 2025 THE PATIENT¿S WIFE REPORTED THE PATIENT DIED DUE TO A FAULTY INSULIN PUMP. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2). REF REPORT: MW5170109.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 5/14/2025 FOR REPORT MW5170108 TO UPDATE PROCODE: QFG. REF REPORT: MW5170109.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    945433 TANDEM INSULIN PUMP ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG TANDEM DIABETES CARE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death