BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CHEMISTRY 1800

    MDR report key: 2230867 · Received September 1, 2011

    Report

    Report Number
    2432235-2011-00119
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    July 13, 2011
    Report Date
    August 2, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    JJE
    PMA / PMN Number
    K990346
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS TECHNICAL SERVICE ENGINEER (TSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER ANALYZING THE INSTRUMENT DATA IT WAS DETERMINED THAT THE CAUSE OF THE DISCORDANT CALCIUM RESULT IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT HIGH ADVIA CHEMISTRY 1800 CALCIUM RESULT WAS OBTAINED ON ONE PATIENT. RESULT WAS REPORTED TO THE PHYSICIAN. THE SAMPLE WAS RETESTED BY THE LABORATORY ON THE SAME INSTRUMENT AND AT AN ALTERNATE LABORATORY. THERE IS NO REPORT OF ADVERSE HEALTH CONSEQUENCES OR PATIENT INTERVENTION DUE TO THE DISCORDANT CALCIUM RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CHEMISTRY 1800 CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CHEMISTRY 1800 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1