BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR RUBELLA G (RUB G) ASSAY

    MDR report key: 1616629 · Received February 22, 2010

    Report

    Report Number
    1219913-2010-00023
    Event Type
    Other
    Date Received
    February 22, 2010
    Date of Event
    February 3, 2010
    Report Date
    February 9, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    LFX
    PMA / PMN Number
    K003412
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT RUBELLA G RESULT WITH OTHER METHODS IS UNK. A SIEMENS REPRESENTATIVE EXAMINED THE RUBELLA G QC AND NO ISSUES WERE FOUND. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A POSITIVE ADVIA CENTAUR RUBELLA G RESULT WAS OBTAINED ON A PT SAMPLE. THE CUSTOMER HAS A PROTOCOL TO RETEST ANY RESULT BETWEEN 10-50. THE SAMPLE WAS TESTED ON THE IMMULITE PLATFORM AND THE RESULT WAS NEGATIVE . THE PT SAMPLE WAS TESTED ON THE ARCHITECT PLATFORM AND THE RESULT WAS NEGATIVE. THE SAMPLE WAS REPEATED ON THE ADVIA CENTAUR PLATFORM AND THE RESULT WAS SIMILAR. DUE TO THE DISCORDANCY BETWEEN PLATFORMS, THE RESULT WAS REPORTED AS EQUIVOCAL. PT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RUBELLA G RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR RUBELLA G (RUB G) ASSAY RUB G IMMUNOASSAY LFX SIEMENS HEALTHCARE DIAGNOSTICS INC. NA 156

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR