BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4801015 · Received May 27, 2015

    Report

    Report Number
    3007981285-2015-32978
    Event Type
    Injury
    Date Received
    May 27, 2015
    Date of Event
    May 7, 2015
    Report Date
    May 11, 2015
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED ON (B)(6) 2015 DUE TO ELEVATED BLOOD GLUCOSE LEVELS (+1,000 MG/DL). TROUBLESHOOTING WAS PERFORMED AND PUMP PASSED DELIVERY SYSTEM CHECK. REPORTEDLY, THE CUSTOMER HAD AN ULCER ON HIS LEG THAT APPEARED TO BE INFECTED. CUSTOMER WAS TREATED THROUGH INTRAVENOUS INSULIN DRIP, FLUIDS, AND ANTIBIOTICS, AND RELEASED FROM THE HOSPITAL ON (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342292 TANDEM T:SLIM INSULIN DELIVERY SYSTEM LZG TANDEM DIABETES CARE INC. 004628 M013527

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R INSULIN: HUMALOG| INFUSION SET: INSET