BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 3940226 · Received June 20, 2014

    Report

    Report Number
    3007981285-2014-02032
    Event Type
    Injury
    Date Received
    June 20, 2014
    Date of Event
    May 18, 2014
    Report Date
    May 21, 2014
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED FOR EVAL; HOWEVER, THE DEVICE EVAL IS NOT YET COMPLETE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAS EXPERIENCED HIGH BG LEVELS (APPROX 400). THE CUSTOMER THEN TREATED HIMSELF WITH MULTIPLE CORRECTION BOLUSES THAT HE CALCULATED WITHOUT USING THE PUMP. HE THEN WENT INTO INSULIN SHOCK AND THE PARAMEDICS WERE CALLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362453 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628 M002750

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R