BEUDAMED
    FDA Adverse Event Summary report: N

    IMMULITE 2000

    MDR report key: 2103627 · Received May 26, 2011

    Report

    Report Number
    2247117-2011-00031
    Date Received
    May 26, 2011
    Date of Event
    April 26, 2011
    Report Date
    April 27, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K970227
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DISCORDANT HIGH IMMULITE 2000 HCG RESULTS WERE GENERATED ON ONE (1) PATIENT SAMPLE. A PATIENT WITH A POSSIBLE ECTOPIC PREGNANCY DIAGNOSIS WAS GIVEN METHOTREXATE (2 DOSES) TO FACILITATE A MISCARRIAGE. THE RESULTS FOLLOWING THE MEDICATION WERE QUESTIONED BY THE PHYSICIAN. THE LABORATORY REPEATED THREE SAMPLES BASED ON THE PHYSICIAN'S REQUEST IN ORDER TO DETERMINE IF A SURGICAL PROCEDURE WAS NEEDED TO COMPLETE THE MISCARRIAGE. THERE WAS 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 JJE SIEMENS HEALTHCARE DIAGNOSTICS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1