BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 2400

    MDR report key: 3082784 · Received April 29, 2013

    Report

    Report Number
    2432235-2013-00158
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 4, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K990346
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATION OF THE INSTRUMENT AND INSTRUMENT DATA, THE FSE DISCOVERED THAT THE ARM OF PROBE 2 WAS BENT. THE FSE REALIGNED THE PROBE ARM AND THE PROBE HEIGHT. THE FSE THEN RAN PRECISION WITH CALCIUM SAMPLES, AND THE PRECISION RESULTS WERE ALL WITHIN SPECIFICATIONS. THE CAUSE OF THE DISCORDANT CALCIUM RESULTS WAS A MALFUNCTION OF THE PROBE. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT CALCIUM RESULTS WERE OBTAINED ON FOUR PATIENT SAMPLES ON AN ADVIA 2400 INSTRUMENT. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE RERUN ON THE SAME INSTRUMENT AND RESULTED AS EXPECTED, AND THE RERUN RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CALCIUM RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185555 ADVIA 2400 CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS ADVIA 2400

    Patients

    Seq Age Sex Outcome Treatment
    1