BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR RUBELLA G (RUB G) ASSAY

    MDR report key: 1315781 · Received February 17, 2009

    Report

    Report Number
    1219913-2009-00015
    Event Type
    Other
    Date Received
    February 17, 2009
    Date of Event
    February 5, 2009
    Report Date
    February 6, 2009
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    LFX
    PMA / PMN Number
    K003412
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD APPLICATION SPECIALIST (FAS) WAS ON-SITE. THE FAS CHECKED THE INSTRUMENT AND CONFIRMED THAT THE INSTRUMENT WORKS PROPERLY. THE CAUSE FOR THE DISCORDANT RUB G RESULT IS UNK. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    THREE FALSE POSITIVE ADVIA CENTAUR RUBELLA G RESULTS WERE OBTAINED ON PT SAMPLES, AS COMPARED TO ANOTHER METHOD USED FOR TESTING. THE PHYSICIAN IS CONCERNED ABOUT IMMUNIZATION STATUS OF A PREGNANT WOMAN. PT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RUB G RESULT.

    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 151

    Patients

    Seq Age Sex Outcome Treatment
    1