BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4852560 · Received June 17, 2015

    Report

    Report Number
    3007981285-2015-36104
    Event Type
    Injury
    Date Received
    June 17, 2015
    Date of Event
    March 1, 2015
    Report Date
    May 27, 2015
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT RETURNING FOR EVAL. SHOULD NEW RELEVANT INFO BECOME AVAILABLE A SUPPLEMENTAL FORM WILL BE COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED FLUCTUATING BLOOD GLUCOSE LEVELS. NO FURTHER INFO ON THE REPORTED ISSUE WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394547 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other