BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP

    MDR report key: 6883949 · Received September 21, 2017

    Report

    Report Number
    3007981285-2017-26895
    Event Type
    Injury
    Date Received
    September 21, 2017
    Date of Event
    January 5, 2017
    Report Date
    September 21, 2017
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP BATTERY WAS OBSERVED TO BE DEPLETING QUICKLY. REPORTEDLY, THE BATTERY ONLY LASTS TWO DAYS. THE CUSTOMER¿S BLOOD GLUCOSE (BG) LEVEL WAS 250-350 (MG/DL). A BOLUS VIA THE PUMP OR A MANUAL INJECTION WERE USED TO ADDRESS BG LEVEL. THE CUSTOMER DECLINED TO UPLOAD THE PUMP DATA LOGS FOR REVIEW BY TANDEM TECHNICAL SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662691 T:SLIM X2 INSULIN PUMP INSULIN PUMP LZG TANDEM DIABETES CARE 1000096

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other