BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:FLEX INSULIN DELIVERY SYSTEM

    MDR report key: 7706555 · Received July 20, 2018

    Report

    Report Number
    3013756811-2018-25363
    Event Type
    Malfunction
    Date Received
    July 20, 2018
    Date of Event
    July 10, 2018
    Report Date
    July 20, 2018
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    UDI-DI
    00852162004576518645
    PMA / PMN Number
    K143189
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MULTIPLE, INTERMITTENT OCCLUSION ALARMS OCCURRED. INFUSION SET SITE CHANGES WERE PERFORMED RESOLVING THE OCCLUSIONS. CUSTOMER'S BLOOD GLUCOSE LEVEL RANGED BETWEEN 220-280 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549687 T:FLEX INSULIN DELIVERY SYSTEM INFUSION PUMP LZG TANDEM DIABETES CARE 004628-005 00852162004576518645

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR