BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 10960341 · Received December 7, 2020

    Report

    Report Number
    3013756811-2020-136105
    Event Type
    Malfunction
    Date Received
    December 7, 2020
    Date of Event
    November 17, 2020
    Report Date
    December 7, 2020
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    UDI-DI
    00852162004545
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 INTERMITTENT OCCLUSION ALARMS OCCURRED. ADDITIONALLY, IT WAS REPORTED THAT A CARTRIDGE ALARM (ALARM 19) OCCURRED DURING BASAL DELIVERY. REPORTEDLY, THE PUMP SUPPLIES WERE CHANGED TO ADDRESS THE ISSUE. CUSTOMER REVERTED TO AN ALTERNATE PUMP FOR INSULIN THERAPY. CUSTOMER'S BLOOD GLUCOSE RANGED FROM 252-454 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1425784 T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628 00852162004545

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR