BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 6764481 · Received August 3, 2017

    Report

    Report Number
    3007981285-2017-22543
    Event Type
    Injury
    Date Received
    August 3, 2017
    Date of Event
    June 28, 2017
    Report Date
    August 3, 2017
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER NEEDED TO ADJUST THE CORRECTION FACTOR SETTING ON THE PUMP. REPORTEDLY, THE CUSTOMER'S DOCTOR RECOMMENDED TO CHANGE THE VALUE BY 20%. TANDEM TECHNICAL SUPPORT ADVISED THE CUSTOMER THAT SPECIFIC VALUES WERE TO BE INPUT, AND THOSE CHANGES WERE ABLE TO BE MADE IN THE CUSTOMER'S PERSONAL PROFILE; THE CUSTOMER ACKNOWLEDGED. THE CUSTOMER'S BLOOD GLUCOSE LEVEL RANGED FROM 250-460 MG/DL AND WAS ADDRESSED WITH THE PUMP. ADDITIONALLY, IT WAS REPORTED THAT THE THERE WERE AIR BUBBLES IN THE PIG TAIL TUBING FROM THE CARTRIDGE. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 480 MG/DL AND WAS ADDRESSED BY CHANGING SUPPLIES AND RESUMING INSULIN DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544181 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other