BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 10228138 · Received July 3, 2020

    Report

    Report Number
    3013756811-2020-68748
    Event Type
    Injury
    Date Received
    July 3, 2020
    Date of Event
    June 11, 2020
    Report Date
    July 2, 2020
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00853052007264
    PMA / PMN Number
    P180008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER TANDEM USER GUIDE: TANDEM DIABETES CARE RECOMMENDS THAT YOU PERIODICALLY CHECK THE BATTERY LEVEL INDICATOR, CHARGE THE PUMP FOR A SHORT PERIOD OF TIME EVERY DAY (10 TO 15 MINUTES), AND AVOID FREQUENT FULL DISCHARGES. 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 THE PUMP TURNED OFF DUE TO NORMAL BATTERY DEPLETION. ADDITIONALLY, IT WAS REPORTED THAT A MINIMUM FILL NOTIFICATION OCCURRED AFTER RELOADING THE CARTRIDGE. REPORTEDLY, THE CARTRIDGE HAD 160-170 UNITS. CUSTOMER'S BLOOD GLUCOSE (BG) RANGED FROM 100-538 MG/DL. REPORTEDLY, CUSTOMER ADMINISTERED MANUAL INJECTIONS TO TREAT LOW BG. REPORTEDLY, CUSTOMER LOADED A NEW CARTRIDGE TO ADDRESS ISSUE AND RESUME INSULIN DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694683 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 41 YR Other