BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP CORTISOL (COR) ASSAY

    MDR report key: 2494502 · Received March 16, 2012

    Report

    Report Number
    1219913-2012-00132
    Event Type
    Malfunction
    Date Received
    March 16, 2012
    Date of Event
    December 15, 2011
    Report Date
    December 19, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    JFT
    PMA / PMN Number
    K962559
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    SIEMENS HAS INVESTIGATED AND CONFIRMED THE CUSTOMER'S OBSERVATION OF REAGENT PACK SOLID PHASE BANDING (LINES) THAT AFFECTS THE ONBOARD STABILITY OF THE REAGENTS WHICH HAS THE POTENTIAL TO AFFECT BOTH CONTROLS AND PATIENT RESULTS OVER THE ONBOARD STABILITY PERIOD. AN URGENT FIELD SAFETY NOTICE ((B)(4)) WAS DISTRIBUTED TO CUSTOMERS IN (B)(6) 2012 TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER HAS OBSERVED ACCUMULATION OF SOLID PHASE PARTICLES LINES ON THE SIDES OF THE ADVIA CENTAUR XP CORTISOL REAGENT READY PACKS AND FAILED QUALITY CONTROL RESULTS WITHIN ONBOARD STABILITY. THE SIEMENS TECHNICAL APPLICATION SPECIALIST (TAS) MIXED THE REAGENT PACK AND THE QUALITY CONTROL WAS WITHIN RANGE. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE FAILED ONBOARD CORTISOL QUALITY CONTROL RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR XP CORTISOL (COR) ASSAY CORTISOL IMMUNOASSAY JFT SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 254

    Patients

    Seq Age Sex Outcome Treatment
    1