BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:FLEX INSULIN DELIVERY SYSTEM

    MDR report key: 7718979 · Received July 25, 2018

    Report

    Report Number
    3013756811-2018-26303
    Event Type
    Malfunction
    Date Received
    July 25, 2018
    Date of Event
    July 10, 2018
    Report Date
    July 25, 2018
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    UDI-DI
    00852162004385518946
    PMA / PMN Number
    K143189
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE T:FLEX CARTRIDGE USER GUIDE STATES ¿USE ONLY THE SYRINGE AND NEEDLE PROVIDED BY TANDEM DIABETES CARE, INC. TO FILL THE CARTRIDGE.¿ NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE PUMP USER GUIDE STATES DO NOT REUSE CARTRIDGES OR USE CARTRIDGES OTHER THAN THOSE MANUFACTURED BY TANDEM DIABETES CARE, INC. USE OF CARTRIDGES NOT MANUFACTURED BY TANDEM DIABETES CARE, INC. OR REUSE OF CARTRIDGES MAY RESULT IN OVER DELIVERY OR UNDER DELIVERY OF INSULIN. THIS CAN CAUSE VERY LOW OR VERY HIGH BLOOD GLUCOSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MINIMUM FILL NOTIFICATION OCCURRED AFTER FILLING A CARTRIDGE WITH AN UNKNOWN AMOUNT OF INSULIN. CUSTOMER USED WRONG SYRINGE TO FILL CARTRIDGE. NO IMPACT TO CUSTOMER¿S BLOOD GLUCOSE LEVEL. REPORTEDLY, THE CUSTOMER HAD MANUAL INJECTIONS FOR ALTERNATE INSULIN THERAPY.

    Description of Event or Problem · 1

    ADDITIONALLY, CUSTOMER FILLED A RE-USED CARTRIDGE WITH INSULIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561071 T:FLEX INSULIN DELIVERY SYSTEM INFUSION PUMP LZG TANDEM DIABETES CARE 004628-005 00852162004385518946

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR