BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T: SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 3884195 · Received May 20, 2014

    Report

    Report Number
    3007981285-2014-00734
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    February 1, 2014
    Report Date
    April 21, 2014
    Manufacturer
    TANDEM DIABETES
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT RETURNING FOR EVAL. ATTEMPTS WERE MADE TO OBTAIN ALL AVAILABLE INFO. SHOULD NEW INFO BECOME AVAILABLE, A F/U MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    RECEIVED INFO STATING CUSTOMER HAS RECEIVED FREQUENT ALTITUDE ALARMS WHILE IN FLIGHT AND ALSO AT HOME. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298498 TANDEM T: SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR