BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP

    MDR report key: 6694785 · Received July 7, 2017

    Report

    Report Number
    3007981285-2017-19025
    Event Type
    Injury
    Date Received
    July 7, 2017
    Date of Event
    June 12, 2017
    Report Date
    July 7, 2017
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 HIGH BLOOD GLUCOSE (BG) LEVELS (200-483 MG/DL). THE PUMP SUPPLIES WER CHANGED AND INSULIN INJECTIONS WERE ADMINISTERED TO ADDRESS THE BG LEVEL. THE CUSTOMER DID NOT KNOW THE CAUSE OF THE HIGH BG. A PUMP SYSTEM CHECK WAS PERFORMED USING THE CURRENT SUPPLIES ON THE PUMP AND NO DEVICE ISSUES WERE IDENTIFIED. THE CUSTOMER DECLINED TO REMOVE THE CANNULA TO INSPECT. TANDEM TECHNICAL SUPPORT DISCUSSED HOW THE INFUSION SET (CANNULA) COULD BE COMPROMISED. THE CUSTOMER ACKNOWLEDGED THE INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475267 T:SLIM X2 INSULIN PUMP INSULIN PUMP LZG TANDEM DIABETES CARE 1000096

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other INFUSION SET: T:90, INSULIN: HUMALOG