BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:FLEX INSULIN DELIVERY SYSTEM

    MDR report key: 12128706 · Received July 7, 2021

    Report

    Report Number
    3013756811-2021-73685
    Event Type
    Malfunction
    Date Received
    July 7, 2021
    Date of Event
    June 21, 2021
    Report Date
    July 7, 2021
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    UDI-DI
    00852162004385
    PMA / PMN Number
    K143189
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED AND EVALUATION IS PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INTERMITTENT OCCLUSION ALARMS OCCURRED. CUSTOMER WAS UNABLE TO COMPLETE SYSTEM CHECK WITH TANDEM TECHNICAL SUPPORT AT TIME OF CALL. UPON FOLLOW UP, CUSTOMER HAD SUCCESSFULLY RESUMED INSULIN DELIVERY. CUSTOMER'S BLOOD GLUCOSE WAS 113-131 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1028819 T:FLEX INSULIN DELIVERY SYSTEM INFUSION PUMP LZG TANDEM DIABETES CARE 004628-005 00852162004385

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR INFUSION SET: AUTOSOFT XCINSULIN: NOVOLOG| INFUSION SET: AUTOSOFT XCINSULIN: NOVOLOG