BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 2120

    MDR report key: 2595946 · Received June 1, 2012

    Report

    Report Number
    2432235-2012-00169
    Event Type
    Malfunction
    Date Received
    June 1, 2012
    Date of Event
    May 22, 2012
    Report Date
    May 22, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    GKL
    PMA / PMN Number
    K042251
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED TO THE CUSTOMER SITE TO EVALUATE THE ADVIA 2120 INSTRUMENT . AFTER ANALYSIS OF THE INSTRUMENT THE FSE CLEANED ALL THE PORTS AND CHANGED THE DIAGHRAM PUMPS. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS NEEDED.

    Description of Event or Problem · 1

    DISCORDANT HIGH ADVIA 2120 HEMOGLOBIN RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES THE CUSTOMER NOTICED THAT THE CONTROLS WERE OUT OF RANGE AND STOPPED USING THE INSTRUMENT, HOWEVER RESULTS HAD BEEN SENT TO THE PHYSICIAN(S) THE SAMPLES WERE REPEATED ON AN ALTERNATE SYSTEM AND CORRECTED REPORTS WERE SENT OUT. THERE IS NO KNOWN REPORT OF TREATMENT GIVEN OR WITHHELD BASED ON THE DISCORDANT HEMOGLOBIN RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1