BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM G5 SYSTEM

    MDR report key: 9140196 · Received October 1, 2019

    Report

    Report Number
    3013756811-2019-63129
    Event Type
    Malfunction
    Date Received
    October 1, 2019
    Date of Event
    September 12, 2019
    Report Date
    October 1, 2019
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    UDI-DI
    00853052007318
    PMA / PMN Number
    P140015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN OCCLUSION ALARM OCCURRED. CUSTOMER'S BLOOD GLUCOSE RANGED FROM 250-374 MG/DL. DURING A PUMP SYSTEM CHECK WITH TANDEM TECHNICAL SUPPORT, A NEW CARTRIDGE WAS LOADED AND A MINIMUM FILL NOTIFICATION WAS RECEIVED. A PUMP AIR LEAK WAS DETECTED. REPORTEDLY, CUSTOMER REVERTED TO MANUAL INJECTIONS FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    932510 T:SLIM G5 SYSTEM CONTINUOUS GLUCOSE MONITOR OYC TANDEM DIABETES CARE 1000096 00853052007318

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR