BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4101168 · Received September 17, 2014

    Report

    Report Number
    3007981285-2014-07329
    Event Type
    Injury
    Date Received
    September 17, 2014
    Date of Event
    August 19, 2014
    Report Date
    August 19, 2014
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED FOR EVAL; HOWEVER, DEVICE EVAL IS NOT YET COMPLETE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREEN ON QUICK BOLUS BUTTON WAS NOT WORKING. THE DEVICE TURNS ON WHEN PLUGGED INTO A POWER SOURCE. THE CUSTOMERS' BLOOD GLUCOSE LEVEL WAS IMPACTED. THE CUSTOMER TOOK A MANUAL INJECTION FOR CORRECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575159 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Other