BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T: SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4122262 · Received September 18, 2014

    Report

    Report Number
    3007981285-2014-07505
    Event Type
    Injury
    Date Received
    September 18, 2014
    Date of Event
    August 22, 2014
    Report Date
    August 24, 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
    MT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    RECEIVED INFORMATION STATING CUSTOMER RECEIVED MULTIPLE OCCLUSION ALARM. CUSTOMER DID NOT ADDRESS THE FIRST TWO OCCLUSION ALARMS; HOWEVER, AFTER THE THIRD OCCLUSION ALARM, CUSTOMER CHANGED OUT THE SITE AND CARTRIDGE. CUSTOMER'S BLOOD GLUCOSE (BG) LEVEL WAS HIGH; HOWEVER, CUSTOMER INITIATED A BOLUS WHICH RESOLVED HIGH BGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579173 TANDEM T: SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628 M002699

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Other