BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP

    MDR report key: 10777714 · Received November 3, 2020

    Report

    Report Number
    3013756811-2020-119314
    Event Type
    Malfunction
    Date Received
    November 3, 2020
    Date of Event
    September 21, 2020
    Report Date
    November 3, 2020
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    UDI-DI
    00853052007240
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED FOR EVALUATION; HOWEVER, DEVICE EVALUATION IS NOT YET COMPLETE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED A BLOOD GLUCOSE (BG) LEVEL RANGING FROM 200-436 MG/DL. THE CUSTOMER ALLEGED THAT THE PUMP WAS NOT DELIVERING INSULIN PROPERLY. PRIOR TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT INDICATED THAT THE PUMP WAS AS INTENDED; HOWEVER, THE CUSTOMER MAINTAINED THAT THE PUMP WAS NOT FUNCTIONING PROPERLY. REPORTEDLY, THE CUSTOMER REVERTED TO MANUAL INJECTIONS FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1245308 T:SLIM X2 INSULIN PUMP INSULIN PUMP LZG TANDEM DIABETES CARE 1000354 00853052007240

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR