BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP

    MDR report key: 6145669 · Received December 5, 2016

    Report

    Report Number
    3007981285-2016-22163
    Event Type
    Malfunction
    Date Received
    December 5, 2016
    Date of Event
    November 13, 2016
    Report Date
    November 13, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER GUIDE STATES THAT THE ALARM NOTIFIES THE USER THAT THERE HAS BEEN NO INTERACTION WITH THE PUMP IN THE SPECIFIED NUMBER OF HOURS AND THE PUMP WILL SHUT DOWN AFTER 30 SECONDS. 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 AN AUTO-OFF ALARM. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 180 MG/DL. THE CUSTOMER REPORTED TO ONLY BE USING THE PUMP FOR BASAL DELIVERY. TANDEM TECHNICAL SUPPORT EDUCATION THE CUSTOMER ON HOW THE AUTO-ALARM WORKS. THE CUSTOMER ACKNOWLEDGED THE INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796696 T:SLIM X2 INSULIN PUMP INSULIN PUMP LZG TANDEM DIABETES CARE 1000096

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR