BEUDAMED
    FDA Adverse Event Other Summary report: N

    LAS CENTRALINK

    MDR report key: 1082579 · Received July 21, 2008

    Report

    Report Number
    2432235-2008-00075
    Event Type
    Other
    Date Received
    July 21, 2008
    Date of Event
    June 16, 2008
    Report Date
    June 16, 2008
    Product Code
    LGD
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DISCORDANT RESULTS WERE DUE TO AN IMPROPER SETTING OF THE REPORTING DECIMALS IN THE LAS CENTRALINK SOFTWARE BY THE OPERATOR. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT RESULTS WERE OBTAINED ON FOURTEEN SAMPLES FOR TOXM. THE FALSE POSITIVE RESULTS WERE RELEASED TO THE PHYSICIANS. IT IS UNKNOWN IF THERE WAS ANY ADVERSE PATIENT INTERVENTION DUE TO THE DISCORDANT PATIENT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAS CENTRALINK DATA MANAGER LGD NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1