BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 10511893 · Received September 9, 2020

    Report

    Report Number
    3013756811-2020-97375
    Event Type
    Injury
    Date Received
    September 9, 2020
    Date of Event
    August 19, 2020
    Report Date
    September 9, 2020
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00085006613373
    PMA / PMN Number
    P180008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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 CONTINUOUS, ONGOING ELEVATED BLOOD GLUCOSE (BG) LEVELS OF 540 MG/DL AND MODERATE LEVELS OF KETONES. A CORRECTION VIA MDI WAS ADMINISTERED AND CORRECTION BOLUSES WERE DELIVERED TO ADDRESS BG. SUSPECTED CAUSE WAS AN UNDEFINED ISSUE WITH THE CONTROL IQ (CIQ) SOFTWARE. A SYSTEM CHECK WAS PERFORMED WAS PERFORMED AND THE PUMP PERFORMED AS INTENDED. THE PUMP DATA WAS REVIEWED AND THE CIQ SOFTWARE WAS FOUND TO BE OPERATING AS INTENDED. IT WAS ALSO OBSERVED THAT THE CUSTOMER MAY NOT HAVE BEEN SETTING UP THE CORRECT SLEEP ACTIVITY IN THE CIQ SOFTWARE ON CERTAIN DAYS. AFTER AN INFUSION SET SITE CHANGE WAS PERFORMED ON THE AFTERNOON OF (B)(6) 2020, THE CUSTOMER¿S BG LEVELS STABILIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    974623 T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO TANDEM DIABETES CARE 1002717 00085006613373

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other