BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T: SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 3905035 · Received May 27, 2014

    Report

    Report Number
    3007981285-2014-00806
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    April 24, 2014
    Report Date
    April 24, 2014
    Manufacturer
    TANDEM DIABETES
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DURING FURTHER TROUBLESHOOTING PATIENT INDICATED SHE WAS ABLE TO TIGHTEN LUER. T: SLIM GUIDE STATES: CHECK THAT YOUR LUER-LOCK CONNECTION BETWEEN THE CARTRIDGE TUBING AND THE INFUSION SET TUBING IS TIGHT AND SECURE.

    Description of Event or Problem · 1

    RECEIVED INFORMATION ALLEGING PATIENT HAS EXPERIENCED HIGH BG'S.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311995 TANDEM T: SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR