BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:FLEX INSULIN DELIVERY SYSTEM

    MDR report key: 8808728 · Received July 19, 2019

    Report

    Report Number
    3013756811-2019-20635
    Event Type
    Malfunction
    Date Received
    July 19, 2019
    Date of Event
    April 1, 2019
    Report Date
    July 19, 2019
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    UDI-DI
    00852162004385
    PMA / PMN Number
    K143189
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    POSSIBLE USE ERRORS: USING OFF-LABEL INSULIN. PER TANDEM¿S T:FLEX USER GUIDE: "ONLY HUMALOG AND NOVOLOG HAVE BEEN TESTED BY TANDEM DIABETES CARE, INC., AND FOUND TO BE COMPATIBLE FOR USE IN THE T:FLEX SYSTEM. IT IS NOT INTENDED FOR USE WITH ANY OTHER DELIVERY SUBSTANCE.¿ PUMP SERIAL NUMBERS: (B)(4). CARTRIDGE LOT NUMBERS: M111346, M140187.

    Description of Event or Problem · 1

    QUARTERLY SUMMARY REPORT FOR ALLEGED OCCLUSION ALARMS. IT WAS REPORTED THAT OCCLUSION ALARMS OCCURRED OR OCCLUSION ALARMS WERE INTERMITTENT. ISSUE WAS RESOLVED BY CLEARING THE ALARM, LOADING A NEW CARTRIDGE, SWITCHING TO LABELED INSULIN, OR REVERTING TO AN ALTERNATE METHOD OF INSULIN THERAPY. THERE WAS NO ADVERSE IMPACT TO THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599976 T:FLEX INSULIN DELIVERY SYSTEM INFUSION PUMP LZG TANDEM DIABETES CARE 004628-005 00852162004385

    Patients

    Seq Age Sex Outcome Treatment
    1 INFUSION SET, INSULIN