BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4526401 · Received February 13, 2015

    Report

    Report Number
    3007981285-2015-20838
    Event Type
    Malfunction
    Date Received
    February 13, 2015
    Date of Event
    January 16, 2015
    Report Date
    January 16, 2015
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN ADDITIONAL LOT NUMBER WAS REPORTED (LOT # M003743). THE DEVICE HAS BEEN RECEIVED FOR EVALUATION; HOWEVER, DEVICE EVALUATION IS NOT YET COMPLETE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION.

    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 (521 MG/DL); HOWEVER, CUSTOMER STATED THAT ELEVATED BLOOD GLUCOSE LEVEL WAS DUE TO BRONCHITIS AND NOT THE PUMP. CUSTOMER ADMINISTERED A MANUAL INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107558 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628 M013853

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR