BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP FSH

    MDR report key: 3531209 · Received December 20, 2013

    Report

    Report Number
    1219913-2013-00312
    Event Type
    Malfunction
    Date Received
    December 20, 2013
    Date of Event
    November 16, 2013
    Report Date
    November 25, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    CGJ
    PMA / PMN Number
    K904649
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS PERFORMED AN INTERNAL STUDY COMPARING ADVIA CENTAUR FSH REAGENT LOT 033186 AND 033188. QUALITY CONTROL MATERIAL RESULTS WERE ALL WITHIN RANGE. PATIENT SAMPLES DID NOT SHOW THE CONSISTENT BIAS OBSERVED BY THE CUSTOMER. THE CUSTOMER GATHERED ADDITIONAL DATA AND DETERMINED THAT THE OVERALL PATIENT BIAS THAT THEY WERE OBSERVING IS 9%. THE ROOT CAUSE OF THE INITIAL POSITIVE BIAS WITH ADVIA CENTAUR XP FSH REAGENT LOT 033188 CANNOT BE DETERMINED BASED ON THE INFORMATION AVAILABLE.

    Description of Event or Problem · 1

    CUSTOMER PERFORMED A METHOD COMPARISON WITH 75 SAMPLES BETWEEN ADVIA CENTAUR XP FSH REAGENT LOTS 033186 AND 033188. THE SAMPLES TESTED WERE ACROSS THE RANGE OF THE ASSAY (0.3 TO 200 MIU/ML). AN AVERAGE POSITIVE BIAS OF 17% WAS OBSERVED BY THE CUSTOMER WITH REAGENT LOT 033188 COMPARED TO REAGENT LOT 033186. THERE WERE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED BASED ON THESE RESULTS. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES BASED ON THESE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669962 ADVIA CENTAUR XP FSH RADIOIMMUNOASSAY, FOLLICLE-STIMULATING HORMONE CGJ SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 033188

    Patients

    Seq Age Sex Outcome Treatment
    1