BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA 1800

    MDR report key: 1931536 · Received December 10, 2010

    Report

    Report Number
    2432235-2010-00174
    Event Type
    Other
    Date Received
    December 10, 2010
    Date of Event
    November 11, 2010
    Report Date
    November 12, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    JGS
    PMA / PMN Number
    K990346
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER WAS AT A CUSTOMER SITE AND CHANGED THE SAMPLE TURN TABLE (STT) SETTING DURING SYSTEM SERVICE. SUBSEQUENTLY, THE CUSTOMER CONTACTED SIEMENS TO REPORT THE INSTRUMENT REPEATEDLY SAMPLED FROM THE SAME SAMPLE POSITION INSTEAD OF ADVANCING. A SIEMENS CUSTOMER SERVICE REP INSTRUCTED THE CUSTOMER TO CHANGE THE INSTRUMENT STT SETTING BACK TO STANDARD CONDITION. THE INSTRUMENT IS PERFORMING WITHIN SPECS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT DIGOXIN RESULT WAS OBTAINED ON AN ADVIA 1800 FOR 1 PT. THE RESULT WAS REPORTED TO THE HEALTHCARE PROVIDER. THE PT SAMPLE WAS REPEATED ON THE SAME ADVIA 1800 SYSTEM AND THE CORRECTED RESULT WAS REPORTED. THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES OR KNOWN PT INTERVENTION DUE TO THE DISCORDANT DIGOXIN RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA 1800 CHEMISTRY ANALYZER JGS SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA 1800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1