BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T: SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4223650 · Received October 31, 2014

    Report

    Report Number
    3007981285-2014-11067
    Event Type
    Injury
    Date Received
    October 31, 2014
    Date of Event
    October 2, 2014
    Report Date
    October 5, 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
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED. A FOLLOW UP SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE HAS BEEN RECEIVED.

    Description of Event or Problem · 1

    RECEIVED INFORMATION REGARDING MULTIPLE CARTRIDGE ALARMS (CARTRIDGE ALARM 19) WITH MULTIPLE CARTRIDGES DURING THE LOAD PROCESS. REPORTEDLY, THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS ELEVATED; HOWEVER, CUSTOMER STATED IT HAS BEEN ELEVATED SINCE CUSTOMER REVERTED TO BACK UP METHOD OF LONG AND SHORT ACTING INSULIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698033 TANDEM T: SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628 M002833

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other