BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 10022544 · Received May 4, 2020

    Report

    Report Number
    3013756811-2020-48299
    Event Type
    Injury
    Date Received
    May 4, 2020
    Date of Event
    March 13, 2020
    Report Date
    May 4, 2020
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00853052007325
    PMA / PMN Number
    P180008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 THE CUSTOMER EXPERIENCED A LOW BLOOD GLUCOSE (BG) LEVEL, VALUE WAS NOT PROVIDED. CUSTOMER CONSUMED 20 GRAMS OF CARBOHYDRATES, HOWEVER, CUSTOMER¿S BG LEVEL CONTINUED TO LOWER. CUSTOMER CONSUMED AN ADDITIONAL 48 GRAMS OF CARBOHYDRATES AND CUSTOMER¿S BG ELEVATED TO 127 MG/DL. THE CAUSE FOR LOW BG LEVEL WAS NO PROVIDED. CUSTOMER DECLINED FURTHER TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484726 T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO TANDEM DIABETES CARE 1000096 00853052007325

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other