BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T: SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 3003928 · Received March 12, 2013

    Report

    Report Number
    3007981285-2013-00013
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 13, 2013
    Manufacturer
    TANDEM DIABETES
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT NOT LIKELY TO LEAD TO SERIOUS INJURY OR 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

    MOTHER REPORTED HER SON WAS EXPERIENCING HIGH BLOOD GLUCOSE LEVELS AND WAS TAKEN TO THE HOSPITAL. ONCE IN THE HOSPITAL, INSULIN WAS ADMINISTERED AND BLOOD GLUCOSE LEVELS WENT DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103124 TANDEM T: SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR