BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 9453644 · Received December 11, 2019

    Report

    Report Number
    3013756811-2019-90244
    Event Type
    Malfunction
    Date Received
    December 11, 2019
    Date of Event
    December 3, 2019
    Report Date
    December 11, 2019
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00853052007264
    PMA / PMN Number
    P180008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER GUIDE STATES: ¿YOUR T:SLIM PUMP CAN STOP INSULIN DELIVERY AND ALERT YOU (OR WHOEVER IS WITH YOU) IF THERE HAS BEEN NO INTERACTION WITH THE PUMP WITHIN A SPECIFIED PERIOD OF TIME. THE DEFAULT FOR THIS ALARM IS PRESET TO 12 HOURS. YOU CAN SET IT ANYWHERE BETWEEN 5 AND 24 HOURS, OR OFF. THIS ALARM NOTIFIES YOU THAT THERE HAS BEEN NO INTERACTION WITH THE PUMP IN THE SPECIFIED NUMBER OF HOURS AND THE PUMP WILL SHUT DOWN AFTER 30 SECONDS.¿ 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 AN AUTO-OFF ALARM OCCURRED. CUSTOMER CONFIRMED THAT THERE HAD BEEN NO INTERACTION WITH THE PUMP FOR AN EXTENDED PERIOD. CUSTOMER ADJUSTED THE AUTO-OFF SAFETY FEATURE TO ADDRESS THE ISSUE. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 183 - 198 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1244779 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 61 YR