BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 3971228 · Received July 8, 2014

    Report

    Report Number
    3007981285-2014-02374
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    June 8, 2014
    Report Date
    June 8, 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
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED FOR EVALUATION; HOWEVER, THE EVALUATION IS NOT COMPLETE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF EVALUATION.

    Description of Event or Problem · 1

    RECEIVED INFORMATION STATING CUSTOMER RECEIVED A SHUTDOWN ALARM. REPORTEDLY THE CUSTOMERS DID NOT KNOW IF BLOOD GLUCOSE LEVEL WAS IMPACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395790 TANDEM T:SLIM INSULIN DELIVERY SYSTEM LZG TANDEM DIABETES CARE INC. 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other