BEUDAMED
    FDA Adverse Event Other Summary report: N

    TANDEM T: SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 3254153 · Received July 24, 2013

    Report

    Report Number
    3007981285-2013-00041
    Event Type
    Other
    Date Received
    July 24, 2013
    Date of Event
    July 7, 2013
    Report Date
    July 8, 2013
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER SPEAKING TO PT, PT INDICATED THAT SHE HAD ENTERED HER BG LEVELS IN THE CARB FIELD INSTEAD OF IN THE BG FIELD. PATIENT CALLED EMERGENCY MEDICAL TECHS (EMT) AND WAS PLACED ON GLUCOSE DRIP. PATIENT WAS TRANSPORTED TO THE EMERGENCY ROOM AND AFTER AN HOUR VOLUNTARILY LEFT THE HOSP WITHOUT SEEING A DOCTOR. THE T: SLIM PUMP HAS SEVERAL BUILT -IN SAFETY FEATURES DESIGNED TO PREVENT UNINTENDED OR ACCIDENTAL ACTIONS, INCLUDING: CONFIRMATION SCREENS BEFORE INSULIN DELIVERY OR SETTINGS CHANGE.

    Description of Event or Problem · 1

    RECEIVED INFO FROM A TANDEM CLINICAL DIABETES SPECIALIST INDICATING SHE WAS INFORMED A PATIENT HAD POSTED IN FACEBOOK SHE HAD ENTERED A SETTING INCORRECTLY AND WAS ADMITTED TO THE EMERGENCY ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344548 TANDEM T: SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Hospitalization