BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 3223766 · Received July 10, 2013

    Report

    Report Number
    3007981285-2013-00032
    Event Type
    Injury
    Date Received
    July 10, 2013
    Date of Event
    June 22, 2013
    Report Date
    June 26, 2013
    Manufacturer
    TANDEM DIABETES
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS NOT BEEN RETURNED FOR EVAL. SHOULD NEW INFORMATION BECOME AVAILABLE, A FOLLOW-UP MDR WILL BE SUBMITTED. 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 INFORMATION FROM A TANDEM EMPLOYEE INDICATING, A PT HAD BEEN HOSPITALIZED DUE TO SUSPECTED DIABETIC KETOACIDOSIS. DURING CONVERSATION WITH PT, PT STATED, SHE HAD EXPERIENCED INSULIN RESISTANCE AND HER DOCTOR DECIDED TO PUT HER ON INSULIN DRIP. PT'S BG LEVELS WERE STABILIZED AND RELEASED FROM HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317878 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Hospitalization| R DEXCOM CGM