BEUDAMED
    FDA Adverse Event Summary report: N

    IMMULITE 2000

    MDR report key: 2072230 · Received April 28, 2011

    Report

    Report Number
    2247117-2011-00025
    Date Received
    April 28, 2011
    Date of Event
    March 24, 2011
    Report Date
    March 29, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K970227
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    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 INDICATES THAT THE CAUSE FOR THE DISCORDANT HCG RESULT WAS UNKNOWN. THE FSE INSPECTED THE DUAL RESOLUTION DILUTER (DRD) AND PROACTIVELY REPLACED THE SEALS AND SPRING. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    ONE DISCORDANT LOW IMMULITE 2000 HCG RESULT WAS OBTAINED ON ONE (1) PATIENT SAMPLE. THE LOW RESULT WAS REPORTED TO THE PHYSICIAN, WHO REQUESTED A CONFIRMATION TO RULE OUT LOSS OF PREGNANCY. THE LABORATORY REPEATED THE SAMPLE AND THE CORRECTED RESULT WAS REPORTED TO THE PHYSICIAN. THE FALSELY LOW VALUE CAUSED THE DOCTOR TO DISCONTINUE THE PROGESTERONE FOR 4 DAYS BEFORE RE-STARTING THERAPY. THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT HCG 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