BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 5851003 · Received August 5, 2016

    Report

    Report Number
    3007981285-2016-93854
    Event Type
    Injury
    Date Received
    August 5, 2016
    Date of Event
    July 1, 2016
    Report Date
    July 14, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 BEEN EXPERIENCING ONGOING HIGH BLOOD GLUCOSE (BG) LEVELS (200-512 MG/DL). THE CUSTOMER WOULD CHANGE THE SUPPLIES AND DELIVER A BOLUS TO ADDRESS THE HIGH BG LEVEL. THE CUSTOMER THOUGHT THAT THERE MIGHT BE AN INSULIN ABSORPTION ISSUE OR AT TIMES HAD WONDERED IF THE PUMP WAS DELIVERING AN ACCURATE AMOUNT OF INSULIN. THE CUSTOMER WAS UNABLE TO TROUBLESHOOT WITH TANDEM CUSTOMER TECHNICAL SUPPORT (CTS) AT THE TIME OF THE REPORT. ALTHOUGH REQUESTED, THE CUSTOMER HAD NOT CONTACTED CTS TO TROUBLESHOOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501412 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other INFUSION SET: INSET