BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T: SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 3941030 · Received June 30, 2014

    Report

    Report Number
    3007981285-2014-01999
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    June 1, 2014
    Report Date
    June 1, 2014
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    T: SLIM USER GUIDE INDICATES, THE CARTRIDGE IS CONTRAINDICATED FOR SE WITH PRODUCTS OTHER THAN HUMALOG AND NOVOLOG. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. SHOULD NEW INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAS EXPERIENCED HIGH BG LEVELS (385 MG/DL). THE CUSTOMER NOTED THAT HIS BG LEVELS HAVE BEEN HIGH SINCE SWITCHING TO APIDRA INSULIN. THE CUSTOMER'S PUMP HISTORY SHOWS AN ALARM OCCLUSION POSSIBLY CAUSED BY THE APIDRA INSULIN RESULTING IN THE REPORTED HIGH BG LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378930 TANDEM T: SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628 M003145

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Other APIDRA