BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4100726 · Received September 12, 2014

    Report

    Report Number
    3007981285-2014-06672
    Event Type
    Injury
    Date Received
    September 12, 2014
    Date of Event
    August 11, 2014
    Report Date
    August 11, 2014
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWUP WITH CUSTOMER INDICATED THE CUSTOMER WAS NOT FEELING WELL BUT BLOOD GLUCOSE LEVEL HAD LOWERED SLIGHTLY TO 325 MG/DL. A SECOND FOLLOWUP INDICATED CUSTOMER WAS FINE. THE PRODUCT HAS NOT BEEN RECEIVED FOR EVALUATION. SHOULD NEW INFORMATION BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    RECEIVED INFORMATION STATING CUSTOMER RECEIVED MULTIPLE OCCLUSION ALARMS. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 345 MG/DL WITH KETONES. DURING SYSTEM CHECK WITH TANDEM TECHNICAL SUPPORT, IT WAS DETERMINED THAT THE INFUSION SET TUBING WAS RELATED TO THE OCCLUSION ALARMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565115 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628 5035530

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Other INFUSION SET: COMFOR SHORT