BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 9474221 · Received December 16, 2019

    Report

    Report Number
    3013756811-2019-93291
    Event Type
    Malfunction
    Date Received
    December 16, 2019
    Date of Event
    December 10, 2019
    Report Date
    December 16, 2019
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00853052007264
    PMA / PMN Number
    P180008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 A CARTRIDGE ALARM (ALARM 1) OCCURRED DURING BOLUS DELIVERY AND PUMP BATTERY GAUGE FLUCTUATED. CUSTOMER'S BLOOD GLUCOSE WAS 141-338 MG/DL. CUSTOMER INSTALLED ANOTHER CARTRIDGE TO RESOLVE THE CARTRIDGE ALARM AND REPORTEDLY, CHARGED PUMP TO ADDRESS THE BATTERY ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1268344 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 8 YR