BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 3955351 · Received June 16, 2014

    Report

    Report Number
    3007981285-2014-01450
    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
    CA, 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 MULTIPLE CARTRIDGE ALARMS (CARTRIDGE ALARM 19) DURING THE LOAD PROCESS. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS NOT IMPACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353003 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628 M000750

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR