BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 3955798 · Received June 25, 2014

    Report

    Report Number
    3007981285-2014-01733
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    May 25, 2014
    Report Date
    May 25, 2014
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 CARTRIDGE ALARM 19 DURING BASAL DELIVERY AND THE LOAD PROCESS. REPORTEDLY, THE CUSTOMER DISCONNECTED FROM THE PUMP AND WENT SWIMMING. THE PUMP ALARMED WHILE THE CUSTOMER WAS DISCONNECTED FROM THE PUMP, AS WELL AS, WHEN THE CUSTOMER WAS ATTEMPTING TO LOAD A NEW CARTRIDGE. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS NOT IMPACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370085 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR