BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 3213831 · Received July 3, 2013

    Report

    Report Number
    3007981285-2013-00033
    Event Type
    Injury
    Date Received
    July 3, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 18, 2013
    Manufacturer
    TANDEM DIABETES
    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

    DURING A CALL FROM THE CDE TO THE HEALTH CARE PRACTITIONER (HCP) IT WAS IDENTIFIED THAT THE PT HAD BEEN LEFT BY HIMSELF AND HAD NOT FOLLOW THE HCP'S ORDERS. DEVICE HAS NOT BEEN RETURNED FOR EVAL. SHOULD NEW INFO BECOME AVAILABLE, A F/U 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 INFO FROM A CLINICAL DIABETES SPECIALISTS (CDS) INDICATING PT WAS TAKEN TO THE EMERGENCY ROOM DUE TO DIABETIC KETOACIDOSIS (DKA).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306400 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Hospitalization| R