BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP

    MDR report key: 6156264 · Received December 8, 2016

    Report

    Report Number
    3007981285-2016-24607
    Event Type
    Injury
    Date Received
    December 8, 2016
    Date of Event
    November 17, 2016
    Report Date
    November 18, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (BRAND NAME- CORRECTED TO "T:SLIM X2 INSULIN PUMP"). (COMMON DEVICE NAME- CORRECTED TO "INSULIN PUMP"). (PROCODE- CORRECTED TO "LZG"). (MODEL #- ADDED "1000096", CATALOG #- ADDED "1000103", SERIAL #- ADDED " (B)(4)", UID #- ADDED "(B)(4)"). PMA/510K #- ADDED "K111210". DEVICE MANUFACTURE DATE- ADDED "10/19/2016".

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED AFTER THEY INTENTIONALLY OVER DELIVERED INSULIN WITH THE PUMP AND EXPERIENCED A LOW BLOOD GLUCOSE (BG) LEVEL; HOWEVER, NO SPECIFIC BG VALUE WAS PROVIDED. NO FURTHER INFORMATION WAS PROVIDED ON THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804728 T:SLIM X2 INSULIN PUMP INSULIN PUMP LZG TANDEM DIABETES CARE 1000096

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Hospitalization| R