BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T: SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4801073 · Received May 27, 2015

    Report

    Report Number
    3007981285-2015-32367
    Event Type
    Injury
    Date Received
    May 27, 2015
    Date of Event
    May 6, 2015
    Report Date
    May 6, 2015
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K11210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT RETURNING FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL FORM WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS VOMITING AND EXPERIENCED ELEVATED BLOOD GLUCOSE LEVELS (923 MG/DL), AND WAS HOSPITALIZED ON (B)(6) , 2015. CUSTOMER WAS TREATED THROUGH INTRAVENOUS INSULIN, POTASSIUM, AND FLUIDS, AND RELEASED FROM THE HOSPITAL ON (B)(6), 2015. REPORTEDLY, PRIOR TO HOSPITALIZATION THE PUMP WAS BEEPING DUE TO RECEIVING MULTIPLE CARTRIDGE ALARM 18. CUSTOMER STATED HE DID NOT KNOW WHAT THE BEEPING WAS, AND DID NOT RESPOND TO THE PUMP TO RESUM INSULIN DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341722 TANDEM T: SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R CLEO 90