BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 3952517 · Received May 15, 2014

    Report

    Report Number
    3007981285-2014-00638
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 17, 2014
    Manufacturer
    TANDEM DIABETES
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RECEIVED FOR EVALUATION; HOWEVER, EVALUATION IS NOT YET COMPLETE. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    RECEIVED INFORMATION STATING THAT THE CUSTOMER RECEIVED AN ALTITUDE ALARM. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290370 TANDEM T:SLIM INSULIN DELIVERY SYSTEM LZG TANDEM DIABETES 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR