BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 3955335 · Received June 16, 2014

    Report

    Report Number
    3007981285-2014-02405
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 16, 2014
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT RETURNING FOR EVALUATION. ATTEMPTS HAVE BEEN MADE TO OBTAIN ALL EVENT INFORMATION. SHOULD NEW INFORMATION BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    RECEIVED INFORMATION REGARDING A CARTRIDGE ALARM 1 DURING BASAL DELIVERY. CUSTOMER WAS NOT CONNECTED TO THE PUMP AND CARTRIDGE HAD SALINE SOLUTION IN IT. THERE WAS NO REPORTED IMPACT TO CUSTOMER'S BLOOD GLUCOSE LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352655 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR