BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR CORTISOL (COR) ASSAY

    MDR report key: 2559408 · Received May 4, 2012

    Report

    Report Number
    1219913-2012-00173
    Event Type
    Malfunction
    Date Received
    May 4, 2012
    Date of Event
    March 7, 2012
    Report Date
    April 5, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    JFT
    PMA / PMN Number
    K962559
    Removal / Correction Number
    Z-1390-2012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    URGENT FIELD SAFETY NOTICE ((B)(4)) WAS PROVIDED AND THE INFORMATION WITHIN WAS REVIEWED WITH THE CUSTOMER FOR UNDERSTANDING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY DID NOT RECEIVE A ADVIA CENTAUR CORTISOL URGENT FIELD SAFETY NOTICE ((B)(4)) THAT WAS DISTRIBUTED TO CUSTOMERS IN MARCH 2012. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR CORTISOL (COR) ASSAY CORTISOL IMMUNOASSAY JFT SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 256

    Patients

    Seq Age Sex Outcome Treatment
    1