BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP

    MDR report key: 7573754 · Received June 6, 2018

    Report

    Report Number
    3013756811-2018-18673
    Event Type
    Malfunction
    Date Received
    June 6, 2018
    Date of Event
    May 14, 2018
    Report Date
    June 6, 2018
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 AN OCCLUSION ALARM OCCURRED. ADDITIONALLY, IT WAS REPORTED THAT THE PUMP FILL ESTIMATE REMAINED STATIC. BLOOD GLUCOSE RANGED FROM 200-284 MG/DL. REPORTEDLY, THE SUPPLIES WERE CHANGED TO ADDRESS THE EVENT AND INSULIN DELIVERY WAS RESUMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415218 T:SLIM X2 INSULIN PUMP INSULIN PUMP LZG TANDEM DIABETES CARE 1000354 M020842

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR