BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 6051296 · Received October 24, 2016

    Report

    Report Number
    3007981285-2016-15976
    Event Type
    Injury
    Date Received
    October 24, 2016
    Date of Event
    September 29, 2016
    Report Date
    October 3, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 MULTIPLE INCIDENTS WITH ELEVATED BLOOD GLUCOSE (BG) LEVELS RANGE ABOVE (200-424 MG/DL) THE CUSTOMER TOOK BOLUSES VIA THE PUMP AND THE HEALTH CARE PROVIDER (HCP) RECOMMENDED THE CUSTOMER TAKE A 10U MANUAL INJECTION TO STABILIZE BG LEVELS. THE CUSTOMER STATED TO HAVE CHANGED INFUSION SET SITE OUT. HOWEVER, BG'S STILL REMAINED ELEVATED. DURING THE CALL WITH TANDEM TECHNICAL SUPPORT (CTS), THE CUSTOMER NOTED LARGE AIR BUBBLE IN THE LUER LOCK. THE CUSTOMER WAS INSTRUCTED TO EXPEL AIR BUBBLE BY PERFORMING FILL TUBING. A SYSTEM CHECK WAS PERFORMED AND INDICATED THAT THE PUMP WAS FUNCTIONING AS INTENDED. THE CUSTOMER STATED TO HAVE RECENTLY STARTED A NEW MEDICINE 2 WEEKS AGO, AND ALSO THAT STARTING THE NIGHT PRIOR HAS HAD PAIN IN KIDNEYS. 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
    701350 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other INFUSION SET: INSET, INSULIN: NOVOLOG