BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4101113 · Received September 17, 2014

    Report

    Report Number
    3007981285-2014-07091
    Event Type
    Injury
    Date Received
    September 17, 2014
    Date of Event
    August 16, 2014
    Report Date
    September 19, 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
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT BEEN RETURNED FOR EVAL. SHOULD NEW RELEVANT INFO BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED MULTIPLE OCCLUSION ALARMS WHILE ATTEMPTING TO BOLUS. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS IMPACTED (350 MG/DL). CUSTOMER REVERTED TO MANUAL INJECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576778 TANDEM T:SLIM INSULIN DELIVERY SYSTEM LZG TANDEM DIABETES CARE INC. 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other INFUSION SET: INSET| INSULIN: NOVOLOG