BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR VB12 ASSAY

    MDR report key: 1874240 · Received October 13, 2010

    Report

    Report Number
    1219913-2010-00121
    Event Type
    Other
    Date Received
    October 13, 2010
    Date of Event
    July 23, 2010
    Report Date
    July 24, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    CDD
    PMA / PMN Number
    K993571
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE FOR SYSTEM INSPECTION. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT VB12 RESULTS IS UNK. THE INSTRUMENTS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT ADVIA CENTAUR XP VB12 RESULTS WERE OBTAINED ON SEVERAL PT SAMPLES. REPEAT TESTING OF THE PT SAMPLES PROVIDED A DIFFERENT RESULT. PT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP VB12 RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR VB12 ASSAY IMMUNOASSAY FOR VITAMIN B12 CDD SIEMENS HEALTHCARE DIAGNOSTICS INC. NA 204

    Patients

    Seq Age Sex Outcome Treatment
    1