BEUDAMED
    FDA Adverse Event Summary report: N

    IMMULITE 2000

    MDR report key: 2060882 · Received April 18, 2011

    Report

    Report Number
    2247117-2011-00023
    Date Received
    April 18, 2011
    Date of Event
    March 20, 2011
    Report Date
    March 25, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K970227
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS TSE (TECHNICAL SERVICE ENGINEER) ANALYZED THE IMMULITE 2000 INSTRUMENT DATA. ANALYSIS OF THE INSTRUMENT DATA INDICATED THAT THE CAUSE FOR THE DISCORDANT HBSAG RESULTS IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT (B)(6) HBSAG IMMULITE 2000 RESULT WAS GENERATED ON ONE (1) PATIENT SAMPLE. THE RESULTS WERE RELEASED AND QUESTIONED BY THE PHYSICIAN. THE LABORATORY REPEATED THE SAMPLE AND THE REPEAT RESULTS WERE REPORTED. THERE WAS NO KNOWN REPORT OF TREATMENT GIVEN OR WITHHELD BASED ON THE DISCORDANT HBSAG RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMULITE 2000 IMMUNO-ASSAY JJE SIEMENS HEALTHCARE DIAGNOSTICS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1