BEUDAMED
    FDA Adverse Event Summary report: N

    ADVIA CENTAUR XP RUBELLA G (RUB G) ASSAY

    MDR report key: 2072482 · Received April 29, 2011

    Report

    Report Number
    1219913-2011-00058
    Date Received
    April 29, 2011
    Date of Event
    March 30, 2011
    Report Date
    April 1, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    LFX
    PMA / PMN Number
    K003412
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE FOR SYSTEM INSPECTION. THE FSE REPLACED THE DIGITAL DILUTER, SAMPLE SYRINGE AND THE ASPIRATE PROBE 2. 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 FALSE POSITIVE ADVIA CENTAUR XP RUBELLA IGG RESULT WAS OBTAINED BY THE CUSTOMER ON A PATIENT SAMPLE. THE PATIENT SAMPLE WAS REPEATED WITH A NEW LOT OF RUBELLA IGG AND THE TEST RESULT WAS NEGATIVE. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO KNOWN REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSE POSITIVE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR XP RUBELLA G (RUB G) ASSAY RUBELLA G IMMUNOASSAY LFX SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 162

    Patients

    Seq Age Sex Outcome Treatment
    1