BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 3760974 · Received April 10, 2014

    Report

    Report Number
    3007981285-2014-00378
    Event Type
    Injury
    Date Received
    April 10, 2014
    Date of Event
    March 7, 2014
    Report Date
    March 12, 2014
    Manufacturer
    TANDEM DIABETES
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT HAS BEEN RETURNED FOR EVALUATION. SHOULD NEW INFO BECOME AVAILABLE, A F/U MDR WILL BE SUBMITTED. DURING FURTHER TROUBLESHOOTING REPORTER INDICATED PATIENT WEARS CARTRIDGE FOR MORE THAN THREE DAYS. T:SLIM USER GUIDE STATES NOVOLOG WAS TESTED UP TO 72 HOURS.

    Description of Event or Problem · 1

    REC'D INFO STATING PATIENT WAS HOSPITALIZED DUE TO HIGH BG'S (600'S) AND KETONES. PATIENT WAS TREATED WITH MANUAL INJECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216215 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Hospitalization| R