BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 2400

    MDR report key: 1843705 · Received September 21, 2010

    Report

    Report Number
    2432235-2010-00129
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    August 23, 2010
    Report Date
    August 23, 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
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. AFTER ANALYZING THE INSTRUMENT AND INSTRUMENT DATA, THE FSE DETERMINED THE HALOGEN LAMP THAT SUPPLIES LIGHT TO A DIFFRACTION GRATING NEEDED TO BE REPLACED. THE LAMP WAS REPLACED AND THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT GLUCOSE RESULTS WERE OBTAINED ON AN ADVIA 2400 FOR 84 PTS. THE RESULTS WERE REPORTED TO THE HEALTHCARE PROVIDED(S). THE PT SAMPLES WERE REPEATED ON ANOTHER ADVIA 2400 SYSTEM AND THE CORRECTED RESULTS WERE REPORTED. THE CUSTOMER DID RERUN DISCORDANT PT RESULTS WHEN THEY RECOGNIZED QC WAS SHIFTING EVERY FEW HOURS. THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES OR KNOWN PT INTERVENTION DUE TO THE DISCORDANT GLUCOSE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA 2400 CHEMISTRY ANALYZER JGS SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 2400 NA

    Patients

    Seq Age Sex Outcome Treatment
    1