BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 16940242 · Received May 16, 2023

    Report

    Report Number
    3013756811-2023-64485
    Event Type
    Malfunction
    Date Received
    May 16, 2023
    Date of Event
    April 25, 2023
    Report Date
    May 16, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00853052007264
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT OCCLUSION ALARMS OCCURRED. CUSTOMER CHANGED SUPPLIES TO ADDRESS THE ISSUE. ADDITIONALLY, IT WAS REPORTED THAT INSULIN DRIPS WERE NOT OBSERVED TO BE EXITING THE TUBING DURING THE LOAD FILL PROCESS. MULTIPLE FOLLOW-UP ATTEMPTS WERE MADE BY TANDEM TECHNICAL SUPPORT; HOWEVER, THE CUSTOMER DID NOT RESPOND. NO ADDITIONAL INFORMATION WAS KNOWN OR REPORTED. CUSTOMER'S BLOOD GLUCOSE WAS 250-264 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1864002 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1000096 00853052007264

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Female INFUSION SET: TRUSTEEL.