BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 6607896 · Received June 2, 2017

    Report

    Report Number
    3007981285-2017-15568
    Event Type
    Injury
    Date Received
    June 2, 2017
    Date of Event
    May 12, 2017
    Report Date
    June 2, 2017
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD BEEN EXPERIENCING ONGOING HIGH BLOOD GLUCOSE (BG) LEVELS (223 - 325 MG/DL) AND INSULIN INJECTIONS WERE ADMINISTERED TO ADDRESS THE BG LEVEL. THE CUSTOMER THOUGHT THAT THE INFUSION SET SITE WAS INSERTED INTO SCAR TISSUE. THERE WAS NO REPORTED DAMAGE TO THE CANNULA. TANDEM TECHNICAL SUPPORT ADVISED THE CUSTOMER TO DISCUSS THE HIGH BG EVENT WITH A HEALTHCARE PROVIDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389760 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other INSULIN: HUMALOG, INFUSION SET: T:90