BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYS

    MDR report key: 3812723 · Received May 5, 2014

    Report

    Report Number
    3007981285-2014-00546
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 14, 2014
    Manufacturer
    TANDEM DIABETES
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED FOR EVALUATION; HOWEVER, DEVICE EVALUATION IS NOT YET COMPLETE. A FOLLOW UP MDR WILL BE FILED.

    Description of Event or Problem · 1

    RECEIVED INFORMATION REGARDING A LEAKY CARTRIDGE. THE CUSTOMER REPORTED THAT THE ALLEGED ISSUE POSSIBLY IMPACTED HER BLOOD GLUCOSE LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267897 TANDEM T:SLIM INSULIN DELIVERY SYS INSULIN PUMP LZG TANDEM DIABETES 004628 M002400

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other