BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 3940293 · Received June 19, 2014

    Report

    Report Number
    3007981285-2014-02126
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    May 19, 2014
    Report Date
    May 19, 2014
    Manufacturer
    TANDEM DIABETES CARE INC
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. SHOULD NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED HIGH BG'S (410 MG/DL) AFTER LUNCH. THE CUSTOMER REPORTEDLY BOLUSED SEVERAL TIMES BUT HIS BG'S WERE UNAFFECTED. THE CUSTOMER THEN TOOK A MANUAL INJECTION OF INSULIN TO CORRECT HIS BG LEVELS. DURING TROUBLESHOOTING, IT APPEARS THAT THE PUMP IS FUNCTIONING AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360394 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSUILN PUMP LZG TANDEM DIABETES CARE INC 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other