BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4584870 · Received March 9, 2015

    Report

    Report Number
    3007981285-2015-23452
    Event Type
    Injury
    Date Received
    March 9, 2015
    Date of Event
    February 11, 2015
    Report Date
    February 12, 2015
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RECEIVED FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BE RECEIVED A SUPPLEMENTAL FORM WILL BE COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CARTRIDGE WAS LEAKING. CUSTOMER EXPERIENCED ELEVATED BLOOD GLUCOSE LEVELS (210-290 MG/DL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161756 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628 M013622

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other