BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 6023075 · Received October 12, 2016

    Report

    Report Number
    3007981285-2016-13113
    Event Type
    Injury
    Date Received
    October 12, 2016
    Date of Event
    September 15, 2016
    Report Date
    September 19, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    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 "UNCONTROLLED" HIGH BLOOD GLUCOSE (BG) LEVELS (284-380 MG/DL). THE CUSTOMER CHANGED THE SUPPLIES ON THE PUMP MULTIPLE TIMES. A BOLUS VIA THE PUMP WOULD BE DELIVERED TO ADDRESS THE BG LEVEL. THE CUSTOMER WAS CONCERNED THAT THE PUMP WAS NOT FUNCTIONING PROPERLY. TANDEM CUSTOMER TECHNICAL SUPPORT (CTS) HAD THE CUSTOMER PERFORM A SYSTEM CHECK USING THE CURRENT SUPPLIES AND THE PUMP WAS FOUND TO BE FUNCTIONING AS INTENDED. THE CUSTOMER THOUGHT THAT HORMONES (POSTPARTUM) MAY BE THE CAUSE OF THE HIGH BG. CTS ADVISED THE CUSTOMER TO DISCUSS THE BG LEVEL WITH A HEALTHCARE PROVIDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673074 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other INFUSION SET: CLEO, INSULIN: HUMALOG