BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4162173 · Received July 16, 2014

    Report

    Report Number
    3007981285-2014-02954
    Event Type
    Malfunction
    Date Received
    July 16, 2014
    Date of Event
    June 20, 2014
    Report Date
    June 20, 2014
    Manufacturer
    TANDEM DIABETES CARE INC
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT RETURNING FOR EVALUATION. SHOULD NEW INFORMATION BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    RECEIVED INFORMATION STATING CUSTOMER DID NOT OBSERVE INSULIN DRIP FROM THE INFUSION SET TUBING DURING THE LOAD PROCESS. CUSTOMER DISCOVERED THAT THE LUER LOCK AND TUBING WERE NOT SECURELY CONNECTED. THERE WAS NO IMPACT TO CUSTOMER'S BLOOD GLUCOSE LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416449 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC 004628 M003127

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR INFUSION SET: INSET