BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 WITH INTEROPERABLE TECHNOLOGY: DEN180058

    MDR report key: 14138070 · Received April 18, 2022

    Report

    Report Number
    3013756811-2022-36628
    Event Type
    Malfunction
    Date Received
    April 18, 2022
    Date of Event
    March 1, 2022
    Report Date
    March 28, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT MULTIPLE INTERMITTENT MINIMUM FILL NOTIFICATIONS OCCURRED AFTER THE USER FILLED THE CARTRIDGE WITH 100-300 UNITS OF INSULIN DURING THE LOAD SEQUENCE. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. CUSTOMER DECLINED TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2715978 T:SLIM X2 WITH INTEROPERABLE TECHNOLOGY: DEN180058 ALTERNATE CONTROLLER ENABLED INFUSION PUMP LZG TANDEM DIABETES CARE 1002717

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown