BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CHEMISTRY 1800

    MDR report key: 2240596 · Received September 9, 2011

    Report

    Report Number
    2432235-2011-00126
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 23, 2011
    Report Date
    August 25, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    JJE
    PMA / PMN Number
    K990346
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS TECHNICAL SERVICE ENGINEER (TSE) EVALUATED THE INSTRUMENT DATA. ANALYSIS OF THE INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT TOTAL BILIRUBIN_2 AND CREATININE_2 RESULT IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT HIGH ADVIA CHEMISTRY 1800 TBILI_2 AND CREA_2 RESULTS WERE OBTAINED ON ONE PATIENT SAMPLE. A SECOND SAMPLE WAS DRAWN THE FOLLOWING DAY AND LOWER PATIENT VALUES WERE GENERATED FOR BOTH ASSAYS. A THIRD SAMPLE WAS THEN DRAWN WITH RESULTS SIMILAR TO DAY ONE. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TBILI_2 AND CREA_2 RESULTS.

    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