BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 5458650 · Received February 24, 2016

    Report

    Report Number
    3007981285-2016-69473
    Event Type
    Malfunction
    Date Received
    February 24, 2016
    Date of Event
    December 1, 2015
    Report Date
    February 4, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 WAS EXPERIENCING HIGH BLOOD GLUCOSE (BG) LEVELS (190-230 MG/DL). THE CUSTOMER WOULD ADDRESS THE BG LEVEL BY DELIVERING A BOLUS VIA THE PUMP OR INSULIN INJECTIONS. THE CUSTOMER STATED THAT ONCE THE LUER LOCK LEAKED AS IT WAS NOT STRAIGHT, BUT WAS ABLE TO BE STRAIGHTENED. THE CUSTOMER ALSO INDICATED THAT THE SETTINGS ON THE PUMP ARE CHANGED WITHOUT CONSULTING THE HEALTHCARE PROVIDER AND THAT A NEW TYPE OF INFUSION SET WAS BEING USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112575 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR