BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR RUBELLA G (RUB G) ASSAY

    MDR report key: 1812601 · Received August 18, 2010

    Report

    Report Number
    1219913-2010-00095
    Event Type
    Other
    Date Received
    August 18, 2010
    Date of Event
    August 5, 2010
    Report Date
    August 5, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    LFX
    PMA / PMN Number
    K003412
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT RUBELLA G RESULT IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT ADVIA CENTAUR RUBELLA G RESULTS WERE OBTAINED ON A PATIENT SAMPLE. THE INITIAL RESULT WAS NEGATIVE FOR THE PATIENT SAMPLE. TESTING WAS REPEATED AND THE RESULT WAS POSITIVE. A POSITIVE RESULT WAS REPORTED TO THE PHYSICIAN. THE PHYSICIAN QUESTIONED THE RESULT. ANOTHER SAMPLE WAS TESTED. THE INITIAL RESULT WAS NEGATIVE AND THE REPEAT RESULT WAS POSITIVE. THE SAMPLE WAS REPEATED AGAIN AND THE RESULT WAS NEGATIVE. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RUBELLA G RESULTS.

    Additional Manufacturer Narrative · 2

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT RUBELLA G RESULT IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 2

    DISCORDANT ADVIA CENTAUR RUBELLA G RESULTS WERE OBTAINED ON A PATIENT SAMPLE. THE INITIAL RESULT WAS NEGATIVE FOR THE PATIENT SAMPLE. TESTING WAS REPEATED AND THE RESULT WAS POSITIVE. A POSITIVE RESULT WAS REPORTED TO THE PHYSICIAN. THE PHYSICIAN QUESTIONED THE RESULT. ANOTHER SAMPLE WAS TESTED. THE INITIAL RESULT WAS NEGATIVE AND THE REPEAT RESULT WAS POSITIVE. THE SAMPLE WAS REPEATED AGAIN AND THE RESULT WAS NEGATIVE. PATIENT 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 159

    Patients

    Seq Age Sex Outcome Treatment
    1
    2