BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR HAV IGM ASSAY

    MDR report key: 1220557 · Received October 30, 2008

    Report

    Report Number
    1219913-2008-00084
    Event Type
    Other
    Date Received
    October 30, 2008
    Date of Event
    September 25, 2008
    Report Date
    September 30, 2008
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    LOL
    PMA / PMN Number
    K081716
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE REACTIVE HAV IGM AND THE NON-REACTIVE HAV TOTAL RESULTS IS UNKNOWN. A SAMPLE FROM THIS PATIENT HAS BEEN REQUESTED FOR FURTHER IN-HOUSE EVALUATION.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED A REACTIVE HAV IGM RESULT AND A NON-REACTIVE HAV TOTAL RESULT FOR A PATIENT'S SAMPLE. PATIENT'S 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 NA 130

    Patients

    Seq Age Sex Outcome Treatment
    1