BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4102273 · Received September 17, 2014

    Report

    Report Number
    3007981285-2014-07386
    Event Type
    Malfunction
    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
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE CUSTOMER DROPPED THE DEVICE THE DISPLAY WAS UNRECOGNIZABLE. THE CUSTOMER WAS ABLE TO UNLOCK THE SCREEN BY PRESSING IN THE LOCATION OF THE UNLOCK BUTTONS BUT THE SCREEN IS UNREADABLE. NO IMPACT TO CUSTOMERS' BLOOD GLUCOSE LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576578 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR