BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 16366459 · Received February 13, 2023

    Report

    Report Number
    3013756811-2023-17461
    Event Type
    Malfunction
    Date Received
    February 13, 2023
    Date of Event
    January 21, 2023
    Report Date
    February 13, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00389152000077
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 OUT OF RANGE ISSUES OCCURRED BETWEEN THE TRANSMITTER AND PUMP GREATER THAN 15 MINUTES, WITH NO CONTINUOUS GLUCOSE MONITOR (CGM) SENSOR READINGS. THE CUSTOMERS BLOOD GLUCOSE LEVEL WAS REPORTED BETWEEN 171- 175 MG/DL. MULTIPLE CONTACT ATTEMPTS WERE MADE BY TANDEM TECHNICAL SUPPORT TO OBTAIN ADDITIONAL INFORMATION REGARDING THE ISSUE; HOWEVER, THE CUSTOMER DID NOT RESPOND. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1654730 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00389152000077

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male