BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4844055 · Received June 12, 2015

    Report

    Report Number
    3007981285-2015-33725
    Event Type
    Malfunction
    Date Received
    June 12, 2015
    Date of Event
    May 13, 2015
    Report Date
    May 15, 2015
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 THE CUSTOMER RECEIVED AN OCCLUSION ALARM DURING BOLUS DELIVERY. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS NOT IMPACTED. AS THE CUSTOMER HAD CHANGED THE CARTRIDGE AND INFUSION SET PRIOR TO CONTACTING TANDEM CUSTOMER TECHNICAL SUPPORT (CTS), A SYSTEM CHECK TO DETERMINE A POSSIBLE CAUSE OF THE OCCLUSION WAS UNABLE TO BE PERFORMED. HOWEVER, CTS TESTED THE CURRENT SUPPLIES AND THEY WERE FOUND TO BE FUNCTIONING AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384133 TANDEM T:SLIM INSULIN DELIVERY SYSTEM LZG TANDEM DIABETES CARE INC. 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR INFUSION SET: INSET| INSULIN: HUMALOG