BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T: SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4100777 · Received September 12, 2014

    Report

    Report Number
    3007981285-2014-08035
    Event Type
    Injury
    Date Received
    September 12, 2014
    Date of Event
    August 31, 2014
    Report Date
    August 31, 2014
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS EXPERIENCING HIGH BLOOD GLUCOSE LEVELS (500 MG/DL). CUSTOMER HAS RECENTLY HAD ADENOID SURGERY. SHE RECEIVED A 3.99 UNIT BOLUS VIA THE PUMP AND DID A TUBING FILL TO STABILIZE HER BLOOD GLUCOSE LEVELS. CUSTOMER IS CURRENTLY USING HUMALOG AND STATES SHE CHANGES HER INFUSION SITE AND INSULIN EVERY THREE DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565035 TANDEM T: SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Other