BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000 RUBELLA IGM

    MDR report key: 2708210 · Received August 21, 2012

    Report

    Report Number
    2432235-2012-00257
    Event Type
    Malfunction
    Date Received
    August 21, 2012
    Date of Event
    July 27, 2012
    Report Date
    July 27, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    LFX
    PMA / PMN Number
    K012077
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE DISCORDANT RUBELLA IGM RESULT WITH LOT # 216 IS UNKNOWN. SIEMENS IS INVESTIGATING THIS ISSUE.

    Description of Event or Problem · 1

    A DISCORDANT, FALSE NEGATIVE RUBELLA IGM RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE IMMULITE 2000 INSTRUMENT WITH LOT # 216. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN, WHO QUESTIONED THE RESULT. THE SAMPLE WAS RERUN TO OBTAIN THE CORRECTED RESULT. THERE WERE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RUBELLA IGM RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMULITE 2000 RUBELLA IGM RUBELLA IGM IMMUNOASSAY LFX SIEMENS HEALTHCARE DIAGNOSTICS IMMULITE 2000 216

    Patients

    Seq Age Sex Outcome Treatment
    1