BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 9324832 · Received November 14, 2019

    Report

    Report Number
    3013756811-2019-78851
    Event Type
    Malfunction
    Date Received
    November 14, 2019
    Date of Event
    October 28, 2019
    Report Date
    November 14, 2019
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    UDI-DI
    00852162004545
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MULTIPLE OCCLUSION ALARMS OCCURRED. CUSTOMER'S BLOOD GLUCOSE RANGED FROM 190-210 MG/DL. A SYSTEM CHECK WAS PERFORMED WITH TANDEM TECHNICAL SUPPORT AND THE OCCLUSION ALARMS WERE VERIFIED. REPORTEDLY, THE CARTRIDGE WAS CHANGED TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1117586 T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628 00852162004545

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR