BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR CP ESTRADOL-6 III ASSAY

    MDR report key: 1933424 · Received December 15, 2010

    Report

    Report Number
    1219913-2010-00158
    Event Type
    Other
    Date Received
    December 15, 2010
    Date of Event
    November 19, 2010
    Report Date
    November 22, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    CHP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE FOR SYSTEM INSPECTION. THE FSE PERFORMED SYSTEM PREVENTATIVE MAINTENANCE. THE CAUSE FOR THE DISCORDANT ADVIA CENTAUR CP ESTRADIOL-6 III RESULTS IS UNK. NO CONCLUSION CAN BE DRAWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT LOW ADVIA CENTAUR CP ESTRODIOL-6 III ASSAY RESULT WAS OBTAINED ON THE PT SAMPLE. THE PHYSICIAN QUESTIONED THE RESULT AND REPEAT TESTING PERFORMED. THE PT'S MEDICATION WAS INCREASED BASED UPON THE INITIAL AND REPEAT TEST RESULTS. A NEW SAMPLE WAS DRAWN AND THE RESULTS AS WELL AS A REPEAT OF THE INITIAL TEST SAMPLE WERE ELEVATED. THERE WAS NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE INITIAL DISCORDANT LOW ESTRADIOL-6 III RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR CP ESTRADOL-6 III ASSAY E2-6 III IMMUNOASSAY CHP SIEMENS HEALTHCARE DIAGNOSTICS INC NA 135

    Patients

    Seq Age Sex Outcome Treatment
    1