BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4122281 · Received September 18, 2014

    Report

    Report Number
    3007981285-2014-07828
    Event Type
    Injury
    Date Received
    September 18, 2014
    Date of Event
    August 20, 2014
    Report Date
    August 20, 2014
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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

    RECEIVED INFORMATION THAT WHEN THE CUSTOMER'S PUMP WAS REPLUGGED AFTER BEING COMPLETELY DISCHARGED, THE INSULIN GAUGE DISPLAYED 0 EVEN THOUGH 300 UNITS OF HUMALOG WERE ADDED. CUSTOMER PERFORMED A "CARTRIDGE CHANGE" TO RESET THIS VALUE, BUT DURING THE LOAD PROCESS, THE PUMP PROMPTED THAT A MINIMUM OF 50 UNITS WERE REQUIRED TO PROCEED. THIS ISSUE ELEVATED THE CUSTOMER'S BLOOD GLUCOSE LEVEL TO 219 MG/DL, BUT HE SWITCHED TO MDI PENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579069 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other INSULIN: HUMALOG