BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4102238 · Received September 17, 2014

    Report

    Report Number
    3007981285-2014-06955
    Event Type
    Malfunction
    Date Received
    September 17, 2014
    Date of Event
    August 17, 2014
    Report Date
    August 17, 2014
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RECEIVED FOR EVALUATION. SHOULD ADDITIONAL INFO BE RECEIVED A SUPPLEMENTAL FORM WILL BE COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREEN ON/QUICK BOLUS BUTTON IS NOT FUNCTIONING PROPERLY. THE BUTTON NEEDS TO BE DEPRESSED ON THE RIGHT SIDE. IT WAS ALSO REPORTED THAT THE AT TIMES THE BUTTON WOULD GIVE AN OVER DELIVERY (2 CLICKS INSTEAD OF 1). THE DEVICE TURNS ON WHEN PLUGGED INTO A POWER SOURCE. THE CUSTOMERS' BLOOD GLUCOSE LEVEL WAS NOT IMPACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576733 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR