BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T: SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4101143 · Received September 17, 2014

    Report

    Report Number
    3007981285-2014-08499
    Event Type
    Injury
    Date Received
    September 17, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 4, 2014
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RECEIVED FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A SUPPLEMENTAL FORM WILL BE COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD HIGH BLOOD GLUCOSE LEVELS (600 MG/DL). CUSTOMER REPORTS INSULIN LEAKING AT THE CARTRIDGE AND PATIENT LINE CONNECTION. CUSTOMER TOOK A BOLUS, AND SWITCHED OUT HER CARTRIDGE AND INFUSION SET TO STABILIZE HER BLOOD GLUCOSE LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575893 TANDEM T: SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. M001960

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Other