BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 1800

    MDR report key: 5749718 · Received June 25, 2016

    Report

    Report Number
    2432235-2016-00347
    Event Type
    Malfunction
    Date Received
    June 25, 2016
    Date of Event
    May 12, 2016
    Report Date
    June 25, 2016
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K990346
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER CALLED A SIEMENS TECHNICAL APPLICATIONS SPECIALIST (TAS). THE TAS REVIEWED THE INSTRUMENT SETUP OF THE CK METHOD IN CENTRALINK. THE TAS FOUND THAT THE UPPER LIMIT WAS LISTED AS "?" WHICH WOULD ALLOW ALL RESULTS ABOVE ASSAY RANGE TO CROSS TO THE LABORATORY INFORMATION SYSTEM WITHOUT BEING FORMATTED AS A "GREATER THAN (>)" OR "LESS THAN (<)" RESULT. THE TAS THEN PERFORMED A QUERY IN CENTRALINK FOR ALL CK RESULTS IN THE PAST MONTH AND FOUND MULTIPLE REPORTS THAT HAD RESULTS OF GREATER THAN 1,300 THAT WERE REPORTED WITH THE ACTUAL CONCENTRATION. THE TAS FOUND THE "K" (MAXIMUM ABSORBANCE LIMIT EXCEEDED) FLAGGED RESULT OF THE SAMPLE IN QUESTION IN THIS SEARCH. THE FLAG DOES NOT PROVIDE ANY ABSORPTION READING AND SHOULD BE CONFIRMED BY LAB DEFINED CRITERIA BUT SHOULD NOT BE REPORTED OUT WITHOUT A CONFIRMATION TESTING (RERUN OR DILUTION). THE TAS ADDED A FUNCTION FOR THE CK ASSAY THAT WHEN A "K" FLAG IS REPORTED ON INITIAL TESTING, THE SYSTEM WILL PERFORM AN AUTOMATED DILUTION. THE CAUSE OF THE CUSTOMER REPORTING A FLAGGED CREATINE KINASE RESULT WAS DUE TO A USER ERROR. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A CREATINE KINASE (CK) PATIENT SAMPLE TESTED ON AN ADVIA 1800 INSTRUMENT WAS FLAGGED WITH "K" AND "ABOVE ABSORPTION LIMIT" ERRORS. THE SAMPLE DISPLAYED NO RESULT AND WAS ERRONEOUSLY REPORTED BY THE CUSTOMER AS ABOVE THE ASSAY RANGE. A RERUN OF THE SAMPLE WAS NOT PERFORMED. IT IS UNKNOWN WHAT THE CORRECT VALUE FOR THE PATIENT IS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE CUSTOMER ERRONEOUSLY REPORTING A FLAGGED RESULT AS ABOVE THE ASSAY RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403901 ADVIA 1800 CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 1800

    Patients

    Seq Age Sex Outcome Treatment
    1