BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 12307544 · Received August 11, 2021

    Report

    Report Number
    3013756811-2021-87957
    Event Type
    Malfunction
    Date Received
    August 11, 2021
    Date of Event
    July 5, 2021
    Report Date
    August 11, 2021
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00853052007264
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED THAT INTERMITTENT OCCLUSION ALARMS OCCURRED. CUSTOMER CHANGED PUMP SUPPLIES TO ADDRESS THE ISSUE. SYSTEM CHECK WAS PERFORMED WITH TANDEM TECHNICAL SUPPORT AND IT WAS DISCOVERED CURRENT OCCLUSION WAS CAUSED BY A BLOCKAGE IN THE CARTRIDGE. CUSTOMER CHANGED THE CARTRIDGE AND SUCCESSFULLY RESUMED INSULIN DELIVERY. CUSTOMER'S BLOOD GLUCOSE WAS 240-257 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1205624 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00853052007264

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR INFUSION SET: TRUSTEELINSULIN: NOVOLOG| INFUSION SET: TRUSTEELINSULIN: NOVOLOG