BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4193047 · Received October 21, 2014

    Report

    Report Number
    3007981285-2014-10254
    Event Type
    Injury
    Date Received
    October 21, 2014
    Date of Event
    September 26, 2014
    Report Date
    September 26, 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
    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. T:SLIM USER GUIDE INDICATES, THE CARTRIDGE IS INDICATED AS A RESERVOIR FOR THE DELIVERY OF RAPID-ACTING INSULIN, NOVALOG WAS TESTED FOR UP TO 72 HOURS OF USE AS LABELED. THE CARTRIDGE IS CONTRAINDICATED FOR USER WITH PRODUCTS OTHER THAN HUMALOG AND NOVALOG.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD HIGH BLOOD GLUCOSE LEVELS (200 MG/DL PLUS). CUSTOMER CHANGES HER INFUSION SET EVERY THREE DAYS AND CHANGES HER CARTRIDGE EVERY SIX DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669642 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628 M001737

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other