BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 3131122 · Received May 23, 2013

    Report

    Report Number
    3007981285-2013-00021
    Event Type
    Injury
    Date Received
    May 23, 2013
    Date of Event
    January 1, 2013
    Report Date
    April 24, 2013
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED. A REVIEW OF THE MFG RECORDS INDICATE THE DEVICE WAS MANUFACTURED WITHIN SPECIFICATION AND PASSED ALL REQUIRED TESTING. EVENT NOT LIKELY TO LEAD TO DEATH, T: SLIM USER GUIDE INSTRUCTS USERS TO "ROUTINELY CHECK THEIR BG LEVELS AT LEAST 4 TIMES DAILY (OPTIMALLY 6-8 TIMES DAILY) IN ORDER TO DETECT HYPERGLYCEMIA AND HYPOGLYCEMIA EARLY." ADDITIONALLY, T: SLIM USER GUIDE CAUTIONS USERS "TO PREVENT DKA OR A VERY HIGH BG, YOU MUST BE PREPARED TO INJECT INSULIN IF DELIVERY IS INTERRUPTED FOR ANY REASON." IT IS COMMON PRACTICE FOR INSULIN USERS TO CHECK BLOOD GLUCOSE VALUES FREQUENTLY TO PREVENT LEVELS FROM BECOMING SEVERE ENOUGH TO CAUSE SERIOUS COMPLICATIONS.

    Description of Event or Problem · 1

    RECEIVED INFO FROM THE CUSTOMER'S MOTHER INDICATING HER SON EXPERIENCED HIGH KETONES AND VOMITING. MOTHER ADMINISTERED INSULIN INJECTION AND BLOOD GLUCOSE RETURNED TO NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229596 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Hospitalization| R