BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 2120I

    MDR report key: 2476209 · Received March 2, 2012

    Report

    Report Number
    2432235-2012-00054
    Event Type
    Malfunction
    Date Received
    March 2, 2012
    Date of Event
    February 5, 2012
    Report Date
    February 6, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    GKL
    PMA / PMN Number
    K042251
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS TECHNICAL SUPPORT WAS CONTACTED BY THE CUSTOMER. AFTER EVALUATION OF THE ISSUE, IT WAS DETERMINED THAT THE PATIENT ID (PID) EXCEEDED THE LIMIT OF 14 DIGITS AS DOCUMENTED IN THE SIEMENS MANUAL "COMMUNICATIONS LINKS BETWEEN THE DATA MANAGER AND A HOST COMPUTER". THE RESULT WAS THAT THE PID OF 15 DIGITS WAS TRUNCATED TO 14 RESULTING IN THE PID FOR TWO PATIENTS TO BE THE SAME. WHEN THE DATA MANAGER DID A SEARCH FOR PATIENT DEMOGRAPHICS, IT SELECTED THE FIRST SAMPLE THAT MATCHED THE TRUNCATED PID. THE INSTRUMENT IS WITHIN SPECIFICATION AND OPERATIONAL. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    AN INCORRECT PATIENT ID (PID) WAS REPORTED FOR A SAMPLE ON AN ADVIA 2120I INSTRUMENT. THE PID ASSOCIATED WITH THE SAMPLE DID NOT CORRESPOND TO THE PATIENT NAME IN THE DATA MANAGER. ONLY CORRECTED RESULTS WERE REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES OR PATIENT INTERVENTION DUE TO THE INCORRECT PID.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1