BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM G5 SYSTEM

    MDR report key: 10983859 · Received December 10, 2020

    Report

    Report Number
    3013756811-2020-140727
    Event Type
    Malfunction
    Date Received
    December 10, 2020
    Date of Event
    November 22, 2020
    Report Date
    December 10, 2020
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    UDI-DI
    00853052007318
    PMA / PMN Number
    P140015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN OCCLUSION ALARM OCCURRED. CUSTOMER CHANGED PUMP SUPPLIES TO ADDRESS THE ISSUE AND RESUMED INSULIN DELIVERY. CUSTOMER'S BLOOD GLUCOSE WAS 200-215 MG/DL AT TIME OF ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1450148 T:SLIM G5 SYSTEM CONTINUOUS GLUCOSE MONITOR OYC TANDEM DIABETES CARE 1000354 00853052007318

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR INFUSION SET: AUTOSOFT XCINSULIN: HUMALOG