BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 120

    MDR report key: 2433251 · Received January 31, 2012

    Report

    Report Number
    2432235-2012-00021
    Event Type
    Malfunction
    Date Received
    January 31, 2012
    Date of Event
    January 6, 2012
    Report Date
    January 6, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    GKL
    PMA / PMN Number
    K971998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE TECHNICAL SERVICE CENTER AND WAS DIRECTED TO FLUSH THE HGB REAGENT LINES, WHICH RESOLVED THE ISSUE. IN ADDITION, A SIEMENS FSE (FIELD SERVICE ENGINEER) EVALUATED THE ADVIA 120 INSTRUMENT AND INSTRUMENT DATA. UPON EVALUATING THE INSTRUMENT, THE FSE ADJUSTED THE LASER AND RAN QC. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT LOW HEMOGLOBIN RESULTS WERE OBTAINED ON THE ADVIA 120 FOR TWO PATIENTS. THE RESULTS WERE REPORTED TO THE PHYSICIAN(S) THE SAMPLES WERE REPEATED FOR CONFIRMATION ON THE SAME SYSTEM AND CORRECTED REPORTS WERE SENT OUT. THERE IS NO KNOWN REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT HEMOGLOBIN RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA 120 CHEMISTRY ANALYZER GKL SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA 120 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1