BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4121610 · Received July 29, 2014

    Report

    Report Number
    3007981285-2014-04023
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    June 29, 2014
    Report Date
    June 29, 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
    OTHER

    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 MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    RECEIVED INFORMATION STATING CUSTOMER RECEIVED AN ALTITUDE ALARM WHILE HIKING; THE CUSTOMER DID NOT KNOW IF BLOOD GLUCOSE LEVEL WAS IMPACTED. THE CUSTOMER WAS ABLE TO CLEAR THE ALARM AND CHANGE CARTRIDGE AFTER 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442690 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628 M002509

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR