BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 8276406 · Received January 24, 2019

    Report

    Report Number
    3013756811-2019-04931
    Event Type
    Malfunction
    Date Received
    January 24, 2019
    Date of Event
    January 2, 2019
    Report Date
    January 24, 2019
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00853052007264
    PMA / PMN Number
    P180008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS MISSING DATA POINTS ON THE CONTINUOUS GLUCOSE MONITOR GRAPH. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 161-162 MG/DL. TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT WAS PERFORMED AND DATA POINTS WERE DISPLAYED AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66923 T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO TANDEM DIABETES CARE 1000096 00853052007264

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR