BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000 RUBELLA IGM

    MDR report key: 2902292 · Received January 8, 2013

    Report

    Report Number
    2432235-2013-00007
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    November 30, 2012
    Report Date
    December 12, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    LFX
    PMA / PMN Number
    K012077
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR 2432235-2013-00007 WAS FILED ON JANUARY 9, 2013. ADDITIONAL INFORMATION (02/01/2013): SIEMENS TECHNICAL OPERATIONS EVALUATED IMMULITE 2000 RUBELLA IGM KIT LOTS 218 AND 219, AND NEGATIVE BIAS WAS OBSERVED ON BOTH LOTS. THE CONTROL RANGES WERE REVISED, AND THE NEW RANGES WILL BE PACKAGED WITH THE RUBELLA IGM KITS. THE REVISED RANGES WILL ALSO BE PROVIDED TO CUSTOMERS USING AFFECTED KITS. THE CAUSE OF THE NEGATIVE BIAS ON QUALITY CONTROLS WHEN USING RUBELLA IGM KIT LOT 219 ON AN IMMULITE 2000 XPI INSTRUMENT WAS A QUALITY CONTROL PROBLEM. THIS REAGENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS REAGENT IS REQUIRED.

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE NEGATIVE BIAS ON RUBELLA IGM QUALITY CONTROLS FOR LOT 219 IS UNKNOWN. SIEMENS IS INVESTIGATING THIS ISSUE.

    Description of Event or Problem · 1

    NEGATIVE BIAS WAS OBSERVED ON QUALITY CONTROLS FOR LOT 219 OF THE RUBELLA IGM ASSAY ON AN IMMULITE 2000 XPI INSTRUMENT. IT IS UNKNOWN IF PATIENT SAMPLES HAVE BEEN RUN OR IF ANY PATIENT RESULTS WERE AFFECTED. THERE WERE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE NEGATIVE BIAS ON RUBELLA IGM QUALITY CONTROLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9674 IMMULITE 2000 RUBELLA IGM IMMULITE 2000 RUBELLA IGM LFX SIEMENS HEALTHCARE DIAGNOSTICS IMMULITE 2000 RUBELLA IGM 219

    Patients

    Seq Age Sex Outcome Treatment
    1