BEUDAMED
    FDA Adverse Event Summary report: N

    ADVIA CENTAUR HAV IGM ASSAY

    MDR report key: 2089730 · Received May 16, 2011

    Report

    Report Number
    1219913-2011-00069
    Date Received
    May 16, 2011
    Date of Event
    April 19, 2011
    Report Date
    April 22, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    LOL
    PMA / PMN Number
    K081716
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT (B)(4) RESULTS IS UNKNOWN.THE CALIBRATIONS AND DAILY QC WERE WITHIN RANGE FOR ALL THE RUNS.THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS.NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A (B)(6) ADVIA CENTAUR XP (B)(4) IGM RESULT AND A (B)(6) TOTAL RESULT WERE OBTAINED FOR A PATIENT SAMPLE. THE (B)(6) TOTAL RESULT WAS GENERATED AT A REFERENCE LABORATORY (B)(4). THE PATIENT SAMPLE RESULTS WERE REPEATEDLY POSITIVE FOR HAV IGM AND NEGATIVE FOR (B)(6) TOTAL. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT HAV IGM RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR HAV IGM ASSAY HEPATITIS A VIRUS IGM ASSAY LOL SIEMENS HEALTHCARE DIAGNOSTICS INC. N/A 152

    Patients

    Seq Age Sex Outcome Treatment
    1