BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA 1800

    MDR report key: 1558257 · Received December 9, 2009

    Report

    Report Number
    2432235-2009-00225
    Event Type
    Other
    Date Received
    December 9, 2009
    Date of Event
    November 18, 2009
    Report Date
    November 22, 2009
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    DKH
    PMA / PMN Number
    K990346
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS TECHNICAL SERVICE AND COMPLAINED THAT THEY HAD REPORTED A DISCORDANT PHENYTOIN RESULT BASED ON RESULT FLAGS FROM THE ADVIA 1800. A TECHNICAL SPECIALIST (TS) WORKED WITH THE CUSTOMER VIA TELEPHONE TO ANALYZE THE PROBLEM. BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER THE TS WAS ABLE TO DETERMINE THAT THE REASON FOR THE DISCORDANT RESULT WAS DUE TO INCORRECT CUSTOMER DEFINABLE LOW AND HIGH RANGE FLAG SETTINGS FOR PHENYTOIN, WHICH LED TO AN INCORRECT INTERPRETATION BY THE OPERATOR. THE TS WORKED WITH THE CUSTOMER TO INPUT THE CORRECT FLAG SETTINGS. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT ADVIA 1800 PHENYTOIN RESULTS WERE OBTAINED ON A PATIENT SAMPLE. THE RESULT WAS REPORTED AND THE PHYSICIAN QUESTIONED THE RESULT AFTER TREATING THE PATIENT FOR AN OVERDOSE IN THE EMERGENCY DEPARTMENT. THE SAMPLE WAS REPEATED AND A CORRECTED REPORT WAS ISSUED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES OR PATIENT INTERVENTION DUE TO THE DISCORDANT PHENYTOIN RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA 1800 CHEMISTRY ANALYZER DKH SIEMENS HEALTHCARE DIAGNOSTICS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1