BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T: SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 3913036 · Received May 14, 2014

    Report

    Report Number
    3007981285-2014-00623
    Event Type
    Malfunction
    Date Received
    May 14, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 15, 2014
    Manufacturer
    TANDEM DIABETES
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT BE RETURNED FOR EVALUATION. SHOULD NEW INFORMATION BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREEN ON/QUICK BOLUS BUTTON HAS BECOME STUCK ON MULTIPLE OCCASIONS RESULTING IN THE DELIVERY OF INSULIN BEING STOPPED. THE CUSTOMER ALSO REPORTED HIGH BLOOD GLUCOSE LEVELS (400-500) DUE TO INSULIN DELIVERY BEING STOPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288337 TANDEM T: SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR