BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000

    MDR report key: 2212758 · Received August 16, 2011

    Report

    Report Number
    2247117-2011-00051
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    May 26, 2011
    Report Date
    July 21, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JZO
    PMA / PMN Number
    K970227
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FSE (FIELD SERVICE ENGINEER) ANALYZED THE IMMULITE 2000 INSTRUMENT AND INSTRUMENT DATA. AFTER ANALYZING THE INSTRUMENT AND INSTRUMENT DATA, IT WAS DETERMINED THAT THE CAUSE OF THE DISCORDANT HCG RESULTS IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. NOTE: THE IMMULITE 2000 HCG INSTRUCTION'S FOR USE DO NOT SUPPORT THE USE OF THIS METHOD AS A TUMOUR MARKER.

    Description of Event or Problem · 1

    DISCORDANT IMMULITE 2000 HCG RESULTS WERE GENERATED ON TWO PATIENT SAMPLES. THE CUSTOMER HAD BEEN USING THE HCG ASSAY TO MONITOR AS A TUMOUR MARKER AND THESE PATIENTS HAD BEEN SAMPLED OVER SEVERAL MONTHS. THERE IS NO KNOWN REPORT OF TREATMENT GIVEN OR WITHHELD BASED ON THE DISCORDANT HCG RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1