BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION EXL 200

    MDR report key: 4078909 · Received September 10, 2014

    Report

    Report Number
    1226181-2014-00460
    Event Type
    Malfunction
    Date Received
    September 10, 2014
    Date of Event
    August 4, 2014
    Report Date
    August 15, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K073604
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC). THE CCC SPECIALIST EVALUATED THE FILTER DATA FOR THE SAMPLE AND DETERMINED THAT NO SAMPLE HAD BEEN ALIQUOTTED FOR THE DILUTE TEST. THE CCC SPECIALIST INFORMED THE CUSTOMER THAT THEY WOULD NOT RECEIVE A NUMERICAL DILUTED RESULT IF THE SAMPLE WAS REMOVED FROM ITS POSITION PRIOR TO DILUTION. THE CUSTOMER WAS ADVISED TO VERIFY THAT OPERATORS WERE TRAINED NOT TO TOUCH ANY ON-BOARD SAMPLES WHILE THE SYSTEM WAS RUNNING. THE CAUSES OF THE INSTRUMENT NOT PRODUCING A NUMERICAL VALUE FOR HCG AND THE OPERATOR REPORTING THE HIL RESULT AS AN HCG RESULT WERE DUE TO USER ERROR. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A PATIENT SAMPLE WAS TESTED FOR HUMAN CHORIONIC GONADOTROPIN (HCG) ON A DIMENSION EXL 200 INSTRUMENT. THE SAMPLE RESULTED ABOVE THE DILUTION POINT AND WAS REPEATED UPON DILUTION. THE INSTRUMENT DID NOT PRODUCE A NUMERICAL VALUE FOR THE DILUTED RESULT. THE SAMPLE WAS ALSO TESTED FOR INTERFERENCE DUE TO HEMOLYSIS, ICTERUS, AND LIPEMIA (HIL). THE OPERATOR THEN TOOK THE HIL VALUE AND MANUALLY ENTERED IT INTO THE FIELD FOR THE DILUTED HCG RESULT, WHICH WAS SENT TO THE LABORATORY INFORMATICS SYSTEM (LIS). THE INACCURATE RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS NOT REPEATED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE HIL RESULT BEING REPORTED TO THE PHYSICIAN(S) AS AN HCG RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557584 DIMENSION EXL 200 CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION EXL 200

    Patients

    Seq Age Sex Outcome Treatment
    1