BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 14044817 · Received April 7, 2022

    Report

    Report Number
    3013756811-2022-33417
    Event Type
    Malfunction
    Date Received
    April 7, 2022
    Date of Event
    March 15, 2022
    Report Date
    March 15, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00853052007325
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 THE PUMP BATTERY COULD NOT BE CHARGED. REPORTEDLY, THE CUSTOMER WAS ABLE TO CHARGE THE PUMP WITH A COMPUTER USB OUTLET. CUSTOMER'S BLOOD GLUCOSE VALUE WAS 130-189 MG/DL. REPLACEMENT ADAPTER WAS SENT TO CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1065980 T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO TANDEM DIABETES CARE 1000354 00853052007325

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female