BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:FLEX INSULIN DELIVERY SYSTEM

    MDR report key: 7801782 · Received August 21, 2018

    Report

    Report Number
    3013756811-2018-28306
    Event Type
    Malfunction
    Date Received
    August 21, 2018
    Date of Event
    July 29, 2018
    Report Date
    August 21, 2018
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    UDI-DI
    0085216200456990487319
    PMA / PMN Number
    K143189
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE T:FLEX USER GUIDE STATES: "USE ONLY SINGLE-USE DISPOSABLE CARTRIDGES FROM TANDEM DIABETES CARE. THE EFFICACY OF YOUR T:FLEX SYSTEM CANNOT BE GUARANTEED IF CARTRIDGES OTHER THAN THOSE MANUFACTURED BY TANDEM DIABETES CARE, INC. ARE USED OR IF CARTRIDGES ARE FILLED MORE THAN ONCE." NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MULTIPLE INTERMITTENT ALTITUDE ALARMS OCCURRED AFTER THE CUSTOMER HAD BEEN REUSING THE SAME CARTRIDGE. CUSTOMER'S BLOOD GLUCOSE LEVEL RANGED FROM 55-133 MG/DL. THE CUSTOMER DECLINED TROUBLESHOOTING. TANDEM TECHNICAL SUPPORT EDUCATED THE CUSTOMER REGARDING CARTRIDGE LABELING. REPORTEDLY, THE CUSTOMER WAS ABLE TO RELOAD THE EXISTING CARTRIDGE, ULTIMATELY CLEAR THE ALARM, AND RESUME INSULIN DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644687 T:FLEX INSULIN DELIVERY SYSTEM INFUSION PUMP LZG TANDEM DIABETES CARE 004628-005 0085216200456990487319

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR