BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4193054 · Received October 21, 2014

    Report

    Report Number
    3007981285-2014-09912
    Event Type
    Injury
    Date Received
    October 21, 2014
    Date of Event
    September 24, 2014
    Report Date
    September 25, 2014
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    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. PER TANDEM'S USER GUIDE, "INSULIN SHOULD BE AT ROOM TEMPERATURE BEFORE FILLING CARTRIDGE."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR HAVING HIGH BLOOD GLUCOSE LEVELS (200-600 MG/DL). CUSTOMER WAS TREATED WITH INSULIN INJECTIONS PRIOR TO HOSPITALIZATION. COLD INSULIN IS USED TO FILL CUSTOMERS CARTRIDGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669171 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628 M003537

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Hospitalization| R UNOMEDICAL INSET INFUSION SET