BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4531182 · Received February 19, 2015

    Report

    Report Number
    3007981285-2015-21872
    Event Type
    Injury
    Date Received
    February 19, 2015
    Date of Event
    January 14, 2015
    Report Date
    January 28, 2015
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT RETURNING FOR EVALUATION. SHOULD NEW INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL FORM WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CUSTOMER WAS HOSPITALIZED DUE TO A STOMACH VIRUS. CUSTOMER ALSO EXPERIENCED HIGH BLOOD GLUCOSE LEVELS (200-420 MG/DL). TROUBLESHOOTING WAS PERFORMED AND PUMP PASSED DELIVERY SYSTEM CHECK. CUSTOMER USES U-500 INSULIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119861 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628 M003814

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R INFUSION SET: UNOMEDICAL INSET/INSULIN: U-500