BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:FLEX INSULIN DELIVERY SYSTEM

    MDR report key: 10413381 · Received August 17, 2020

    Report

    Report Number
    3013756811-2020-83767
    Event Type
    Malfunction
    Date Received
    August 17, 2020
    Date of Event
    July 27, 2020
    Report Date
    August 17, 2020
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    UDI-DI
    00852162004385
    PMA / PMN Number
    K143189
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION HAS BEEN COMPLETED. BASED ON THE ANALYSIS, THE ALLEGED MALFUNCTION COULD NOT BE VERIFIED; HOWEVER, A DIFFERENT ISSUE WAS IDENTIFIED.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN GAUGE WAS INACCURATE. ADDITIONALLY IT WAS REPORTED THAT THE PUMP BATTERY WAS OBSERVED TO BE FLUCTUATING. CUSTOMER¿S BLOOD GLUCOSE RANGED FROM 150-153 MG/DL. REPORTEDLY, THE CUSTOMER WILL CONTINUE TO USE CURRENT PUMP UNTIL REPLACEMENT ARRIVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    879486 T:FLEX INSULIN DELIVERY SYSTEM INFUSION PUMP LZG TANDEM DIABETES CARE 004628-005 00852162004385

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR