BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 6146625 · Received December 5, 2016

    Report

    Report Number
    3007981285-2016-22602
    Event Type
    Injury
    Date Received
    December 5, 2016
    Date of Event
    November 12, 2016
    Report Date
    November 14, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 HAD EXPERIENCED BLOOD GLUCOSE (BG) LEVELS RANGE 250-350 MG/DL. THE CUSTOMER DELIVERED BOLUSES VIA THE PUMP TO STABILIZE BG LEVELS. REPORTEDLY, THE SUSPECTED CAUSE OF THE ELEVATED BG LEVELS WAS DUE TO STRESS OF TRAVELING, CHANGE IN DIET AND TIME CHANGE. 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
    795446 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Other