BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 9144890 · Received October 2, 2019

    Report

    Report Number
    3013756811-2019-64074
    Event Type
    Malfunction
    Date Received
    October 2, 2019
    Date of Event
    September 9, 2019
    Report Date
    October 16, 2019
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00852162004781
    PMA / PMN Number
    P180008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (REMOVE BRAND NAME T:SLIM X2 INSULIN PUMP, ADD T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY). (REMOVE COMMON DEVICE NAME INSULIN PUMP, ADD AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND). (REMOVE PROCODE LZG, ADD PROCODE OZO). (REMOVE UID #(B)(4), ADD UID # (B)(4)). (REMOVE PMA/510K #K111210, ADD PMA/510K #P180008).

    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 RECEIVED A CONTINUOUS GLUCOSE MONITOR ERROR 42. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER. REPORTEDLY, THE PUMP WAS RESET TO RESOLVE THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    940538 T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO TANDEM DIABETES CARE 1000096 00852162004781

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR