BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR XP VANCOMYCIN (VANC) ASSAY

    MDR report key: 1927130 · Received December 7, 2010

    Report

    Report Number
    1219913-2010-00145
    Event Type
    Other
    Date Received
    December 7, 2010
    Date of Event
    November 9, 2010
    Report Date
    November 9, 2010
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS, INC
    Product Code
    LEH
    PMA / PMN Number
    K951059
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT VANCOMYCIN RESULTS IS UNK. THE EVENT LOG WAS REVIEWED AND NO ERRORS WERE OBSERVED AROUND THE TIME OF THE DISCORDANT RESULT. THE QC WAS WITHIN RANGE. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATION. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT ADVIA CENTAUR XP VANCOMYCIN RESULTS WERE OBTAINED FOR A PT SAMPLES. A RANDOM DRAW RESULTED IN A HIGH RESULT AND WAS QUESTIONED BY THE PHYSICIAN. REPEAT TESTING WAS PERFORMED ON THE SAMPLE. PT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT VANCOMYCIN RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR XP VANCOMYCIN (VANC) ASSAY VANCOMYCIN IMMUNOASSAY LEH SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS, INC NA 183

    Patients

    Seq Age Sex Outcome Treatment
    1 14 DA