BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 2120

    MDR report key: 2432000 · Received January 30, 2012

    Report

    Report Number
    2432235-2012-00022
    Event Type
    Malfunction
    Date Received
    January 30, 2012
    Date of Event
    January 3, 2012
    Report Date
    January 6, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    GKL
    PMA / PMN Number
    K042251
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FSE (FIELD SERVICE ENGINEER EVALUATED THE ADVIA 2120 INSTRUMENT, AND INSTRUMENT DATA. UPON EVALUATING THE INSTRUMENT, THE FSE REPLACED THE ASPIRATE NEEDLE, RAN PRECISION RUNS AND QC. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT LOW HEMOGLOBIN RESULT WAS OBTAINED ON THE ADVIA 2120 FOR ONE PATIENT AND THE RESULT WAS SENT TO THE PHYSICIAN. THE SAMPLE WAS REPEATED AND A CORRECTED REPORT WAS SENT OUT. THERE IS NO KNOWN REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT HEMOGLOBIN RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA 2120 CHEMISTRY ANALYZER GKL SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA 2120 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1