BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION EXL WITH LM

    MDR report key: 2853412 · Received November 30, 2012

    Report

    Report Number
    1226181-2012-00136
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 2, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    JJE
    PMA / PMN Number
    K944093
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE ANALYZED THE INSTRUMENT. THE CAUSE OF THE AMMONIA IMPRECISION IS UNKNOWN. THE FSE PROACTIVELY ADJUSTED THE TRANSFER SHUTTLE, PERFORMED REAGENT SYRINGE ALIGNMENT, REPLACED THE REAGENT 1 SYRINGE TIP, REPLACED THE LAMP OF THE PHOTOMETER, RAN MULTIPLE PRECISION TESTS AND THEY WERE GOOD. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. FURTHER EVALUATION OF THE DEVICE IS NOT REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER EXPERIENCED IMPRECISION OF AMMONIA ON A DIMENSION EXL INSTRUMENT. ON (B)(6) THE CUSTOMER RAN A SURVEY FOR AMMONIA. ONE OF THE TWO SAMPLES WAS OUT OF EXPECTED RANGE. ON (B)(6) 2012 THE CUSTOMER RAN A PRECISION STUDY WITH PATIENT SAMPLES AND FOUND THAT ONE OF THE SAMPLES RESULTED HIGH VARIATION. THE CUSTOMER USES ANOTHER INSTRUMENT IN THE LABORATORY FOR RUNNING AMMONIA ASSAY. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE IMPRECISION OF AMMONIA ASSAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIMENSION EXL WITH LM CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION EXL WITH LM

    Patients

    Seq Age Sex Outcome Treatment
    1