BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 2400

    MDR report key: 4860267 · Received June 22, 2015

    Report

    Report Number
    2432235-2015-00292
    Event Type
    Malfunction
    Date Received
    June 22, 2015
    Date of Event
    May 21, 2015
    Report Date
    May 28, 2015
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K990346
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC). CCC INSTRUCTED THE CUSTOMER TO REPLACE ALL REAGENTS AND FLUSH ALL PROBES WITH DEIONIZED WATER. THE CAUSE OF THE DISCORDANT CALCIUM RESULTS IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    THE OPERATOR OF AN ADVIA 2400 INSTRUMENT REPORTED ISSUES WITH THE CALCIUM METHOD. THE INITIAL RESULTS WERE FLAGGED AND WERE AUTOMATICALLY RE-RUN ON THE SAME INSTRUMENT, RESULTING WITHIN THE EXPECTED RANGE FOR THE METHOD FOR SOME SAMPLES AND LOW FOR OTHERS. IT IS UNKNOWN IF DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). IT IS UNKNOWN IF THE CORRECTED RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES OR PATIENT INTERVENTION DUE TO THE DISCORDANT CALCIUM RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403696 ADVIA 2400 CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 2400

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability