BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 15501579 · Received September 29, 2022

    Report

    Report Number
    3013756811-2022-104030
    Event Type
    Malfunction
    Date Received
    September 29, 2022
    Date of Event
    September 6, 2022
    Report Date
    October 25, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613786
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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. DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT MULTIPLE MALFUNCTION ALARMS OCCURRED. DURING TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT, THE MALFUNCTION ALARM WAS CLEARED, BUT THEN REOCCURRED. THE CUSTOMER REVERTED TO AN ALTERNATE METHOD OF INSULIN THERAPY. ADDITIONALLY, IT WAS REPORTED THAT THE PUMP DATE WAS INCORRECT. CUSTOMER CORRECTED THE DATE TO RESOLVE THE ISSUE. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 140-350 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2304983 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00850006613786

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Male