BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T: SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4370090 · Received December 23, 2014

    Report

    Report Number
    3007981285-2014-15896
    Event Type
    Injury
    Date Received
    December 23, 2014
    Date of Event
    November 29, 2014
    Report Date
    November 30, 2014
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD HIGH BLOOD GLUCOSE LEVELS (160-190 MG/DL). CUSTOMER CHANGED CARTRIDGE AND INFUSION SET AND FOUND BRUISING AND BLOOD AT HER INFUSION SITE, AND NOTICED AIR BUBBLES IN THE TUBING. PUMP PASSED DELIVERY SYSTEM CHECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846254 TANDEM T: SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628 M007747

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Other UNOMEDICAL INSET INFUSION SET