BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 6650927 · Received June 19, 2017

    Report

    Report Number
    3007981285-2017-17421
    Event Type
    Injury
    Date Received
    June 19, 2017
    Date of Event
    May 25, 2017
    Report Date
    June 19, 2017
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD EXPERIENCED ONGOING ELEVATED BLOOD GLUCOSE (BG) LEVELS RANGING FROM 241-338 (MG/DL) WITH SMALL KETONES. THE CUSTOMER WAS UNCERTAIN OF THE SUSPECTED CAUSE BUT BELIEVED IT MAY BE A PUMP ISSUE. THE CUSTOMER DELIVERED BOLUSES VIA THE PUMP. AS THE CUSTOMER DID NOT CONTACT TANDEM TECHNICAL SUPPORT AT THE TIME OF THE REPORTED ISSUES, TROUBLESHOOTING COULD NOT BE PERFORMED. A RECOMMENDATION WAS MADE FOR THE CUSTOMER TO CONTACT THE HEALTHCARE PROVIDER TO DISCUSS FACTORS THAT MAY AFFECT BG LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432134 T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628 M019548

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Other INFUSION SET: CONTACT DETACH, INSULIN: NOVOLOG