BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMMULITE 2000 HEPATITIS B SURFACE ANTIGEN

    MDR report key: 1321324 · Received February 19, 2009

    Report

    Report Number
    2017183-2009-00005
    Event Type
    Other
    Date Received
    February 19, 2009
    Date of Event
    February 9, 2009
    Report Date
    February 11, 2009
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    LOM
    PMA / PMN Number
    P010050
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF INSTRUMENT AND DATA DID NOT INDICATE SYSTEM ERROR. THE CAUSE FOR THE DISCORDANT (B)(6) RESULT IS UNK. IT IS SUSPECTED THAT THE PT SAMPLE MAY CONTAIN UNK (B)(6) THAT MAY INTERFERE WITH THE ASSAY. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    DISCORDANT IMMULITE 2000 (B)(6) QUALITATIVE ASSAY RESULT WAS OBTAINED ON A PT SAMPLE. THE PT SAMPLE RESULT INDICATED AS NON-REACTIVE ON IMMULITE 2000 ASSAY WHICH RESULTED POSITIVE ON DIFFERENT METHODS. THE RESULT WAS CONFIRMED POSITIVE USING ANOTHER (B)(6) ASSAY. PT TREATMENT WAS NOT ALTERED AND THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT NON-REACTIVE (B)(6) .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMULITE 2000 HEPATITIS B SURFACE ANTIGEN HEPATITIS B SURFACE ANTIGEN IMMUNOASSAY LOM SIEMENS HEALTHCARE DIAGNOSTICS INC. NA 585

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR