BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4894227 · Received July 2, 2015

    Report

    Report Number
    3007981285-2015-37467
    Event Type
    Injury
    Date Received
    July 2, 2015
    Date of Event
    June 9, 2015
    Report Date
    June 9, 2015
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL LOT#: M014297. THE DEVICE IS EXPECTED TO BE RETURNED; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S FILL ESTIMATE WAS INACCURATE. THE CUSTOMER'S BLOOD GLUCOSE (BG) LEVEL WAS 355 MG/DL. THE CUSTOMER INDICATED THEY WOULD CALL THEIR DIABETES EDUCATOR TO DISCUSS HOW TO DEAL WITH THEIR HIGH BGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431238 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP, LZG LZG TANDEM DIABETES CARE INC. 004628 M002603

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other