BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA 2120

    MDR report key: 1731389 · Received June 18, 2010

    Report

    Report Number
    2432235-2010-00085
    Event Type
    Other
    Date Received
    June 18, 2010
    Date of Event
    June 3, 2010
    Report Date
    June 3, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    GKZ
    PMA / PMN Number
    K042251
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. BASED ON THE DATA PROVIDED BY THE CUSTOMER AND ANALYSIS OF THE INSTRUMENT, THE FSE WAS UNABLE TO DETERMINE WHAT CAUSED THE DISCORDANT (B)(6) RESULTS. THE FSE REPLACED A DAMAGED AUTO SAMPLER SAMPLING LINE ON (B)(6) 2010 AND RETURNED ON (B)(6) 2010 TO REPLACE THE AUTO SAMPLER SAMPLING LINE WITH A NEW FITTING. THE SYSTEM IS PERFORMING WITHIN SPECIFICATIONS. THE FSE WILL VISIT THE CUSTOMER SITE AGAIN AND CONFIRM SYSTEM FUNCTIONALITY.

    Description of Event or Problem · 1

    DISCORDANT HEMOGLOBIN (B)(6) RESULTS WERE OBTAINED ON A PATIENT SAMPLE. THE RESULT WAS REPORTED TO THE HEALTHCARE PROVIDER. THE SAMPLE WAS RETESTED AND A CORRECTED REPORT WAS ISSUED. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES OR PATIENT INTERVENTION DUE TO THE DISCORDANT (B)(6) RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA 2120 HEMATOLOGY ANALYZER GKZ SIEMENS HEALTHCARE DIAGNOSTICS INC. 2120 NA

    Patients

    Seq Age Sex Outcome Treatment
    1