BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4771710 · Received May 13, 2015

    Report

    Report Number
    3007981285-2015-32685
    Event Type
    Malfunction
    Date Received
    May 13, 2015
    Date of Event
    April 15, 2015
    Report Date
    April 15, 2015
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT BEEN RETURNED FOR EVAL. SHOULD NEW RELEVANT INFO BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD AN OCCLUSION ALARM DURING BOLUS DELIVERY. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS NOT IMPACTED. TANDEM TECHNICAL SUPPORT OFFERED TO TROUBLESHOOT TO DETERMINE A POSSIBLE CAUSE OF THE OCCLUSION; HOWEVER, THE CUSTOMER DECLINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311854 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR INSULIN: HUMALOG,| INFUSION SET: INSET,