BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 8701370 · Received June 14, 2019

    Report

    Report Number
    3013756811-2019-33965
    Event Type
    Malfunction
    Date Received
    June 14, 2019
    Date of Event
    May 17, 2019
    Report Date
    June 14, 2019
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    UDI-DI
    00852162004552
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INTERMITTENTLY THE PUMP TOUCHSCREEN WAS UNRESPONSIVE AND INTERMITTENTLY, PUMP WAS NOT DISPENSING INSULIN PROPERLY. THERE WAS NO REPORTED IMPACT TO CUSTOMER'S BLOOD GLUCOSE. CONTACT DECLINED TO PROVIDE FURTHER INFORMATION AND DECLINED TANDEM TECHNICAL SUPPORT'S OFFER TO FOLLOW UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492978 T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628 00852162004552

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR