BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 13523757 · Received February 14, 2022

    Report

    Report Number
    3013756811-2022-17494
    Event Type
    Malfunction
    Date Received
    February 14, 2022
    Date of Event
    February 5, 2022
    Report Date
    February 5, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613205
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS EXPECTED TO BE RETURNED; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED AND EVALUATION IS PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN OCCLUSION ALARM OCCURRED. ADDITIONALLY, IT WAS REPORTED THAT RESISTANCE WAS EXPERIENCED DURING THE FILL PROCESS AND THAT MULTIPLE CARTRIDGES DID NOT FIT ONTO THE PUMP. THE CUSTOMER LOADED CARTRIDGES TO RESOLVE THE ISSUES. CUSTOMER¿S BLOOD GLUCOSE LEVEL RANGED FROM 203-210 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90839 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 M426581 00850006613205

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female INSULIN: HUMALOG