BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR

    MDR report key: 1264704 · Received December 11, 2008

    Report

    Report Number
    2432235-2008-00155
    Event Type
    Other
    Date Received
    December 11, 2008
    Date of Event
    November 14, 2008
    Report Date
    November 14, 2008
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    LEH
    PMA / PMN Number
    K971418
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS HEALTHCARE FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCREPANT VANCOMYCIN RESULTS WAS DUE TO THE CRIMPED ACID PUMP OUTLET LINE. THE INSTRUMENT WAS REPAIRED. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCREPANT ADVIA CENTAUR VANCOMYCIN RESULTS WERE OBTAINED ON PT SAMPLES. THE RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE RETESTED AND CORRECTED RESULTS WERE REPORTED. THE CUSTOMER DOES NOT KNOW IF PT INTERVENTION WAS PERFORMED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCREPANT VANCOMYCIN RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR IMMUNOASSAY SYSTEM LEH SIEMENS HEALTHCARE DIAGNOSTICS ADVIA CENTAUR NA

    Patients

    Seq Age Sex Outcome Treatment
    1