BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T: SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4132830 · Received September 29, 2014

    Report

    Report Number
    3007981285-2014-08323
    Event Type
    Injury
    Date Received
    September 29, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 4, 2014
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT BEEN 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 CUSTOMER RECEIVED A MAX BOLUS ALERT. DURING TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT, PUMP HISTORY INDICATED THAT CUSTOMER REQUESTED A BOLUS FOR 221G OF CARBOHYDRATES. CUSTOMER HAD INADVERTENTLY ENTERED HIS BLOOD GLUCOSE LEVEL INTO THE CARBOHYDRATE SECTION. CUSTOMER INDICATED THAT STEPS HAD ALREADY BEGUN TO PREVENT HYPOGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606736 TANDEM T: SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other