BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 8997392 · Received September 11, 2019

    Report

    Report Number
    3013756811-2019-56140
    Event Type
    Malfunction
    Date Received
    September 11, 2019
    Date of Event
    August 21, 2019
    Report Date
    September 11, 2019
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00853052007264
    PMA / PMN Number
    P180008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 THE CUSTOMER RECEIVED A POWER SOURCE ALERT AFTER PLUGGING THE PUMP INTO A WALL OUTLET. DURING TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT, THE CUSTOMER WAS INSTRUCTED TO PLUG THE PUMP INTO A POWER SOURCE FOR AT LEAST 30 MINUTES. CUSTOMER ACKNOWLEDGED. DURING FOLLOW UP, THE CUSTOMER REPORTED THAT THE PUMP BATTERY FULLY DEPLETED AND SUBSEQUENTLY THE PUMP SHUT OFF. CUSTOMER REPORTED THAT THE PUMP HAD POWERED ON AND THE POWER SOURCE ALERT HAD NOT REOCCURRED AFTER CHARGING THE PUMP. THE CUSTOMER¿S BLOOD GLUCOSE WAS BETWEEN 160-176 (MG/DL). REPORTEDLY THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790814 T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO TANDEM DIABETES CARE 1000096 00853052007264

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR