BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000 XPI

    MDR report key: 2830074 · Received November 13, 2012

    Report

    Report Number
    2247117-2012-00098
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 19, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    LFX
    PMA / PMN Number
    P010053/S007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE EVALUATED THE INSTRUMENT AND THE INSTRUMENT DATA. IT WAS DISCOVERED THAT AIR BUBBLES WERE COMING FROM THE IN-LINE FILTER ON THE SAMPLE DILUTOR. THE FSE REPLACED THE WATER LINE FILTER, THE DUAL RESOLUTION DILUTOR SEALS, SAMPLE VALVE, AND SAMPLE PROBE. THE FSE ALSO READJUSTED THE TUBE LIFTER 'UP' POSITION. PRECISION CHECKS WERE THEN RUN ON SAMPLES. THE CAUSE OF THE DISCORDANT RUBELLA IGG RESULTS IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT, FALSELY ELEVATED RUBELLA IGG RESULTS WERE OBTAINED ON SAMPLES FROM TWO PATIENTS ON THE IMMULITE 2000 XPI INSTRUMENT. FOR ONE PATIENT, A DISCORDANT RESULT OF POSITIVE (42.5) FROM (B)(6) 2012 WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE OTHER PATIENT'S DISCORDANT, FALSE POSITIVE RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE RERUN MULTIPLE TIMES, AND THE CORRECTED RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE WERE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RUBELLA IGG RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMULITE 2000 XPI IMMULITE 2000 XPI LFX SIEMENS HEALTHCARE DIAGNOSTICS IMMULITE 2000 XPI

    Patients

    Seq Age Sex Outcome Treatment
    1