BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4163175 · Received September 8, 2014

    Report

    Report Number
    3007981285-2014-09265
    Event Type
    Injury
    Date Received
    September 8, 2014
    Date of Event
    September 16, 2014
    Report Date
    September 16, 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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS WERE MADE TO FOLLOW UP WITH THE CUSTOMER. THE PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CUSTOMER ACCIDENTALLY DELIVERED AN INSULIN BOLUS OF 90 GRAMS INSTEAD OF 60 GRAMS. CONTACT INDICATED THAT HEALTH CARE PROVIDER WOULD BE CONTACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551310 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Other