BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 1800

    MDR report key: 2988223 · Received March 4, 2013

    Report

    Report Number
    2432235-2013-00074
    Event Type
    Malfunction
    Date Received
    March 4, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 5, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K990346
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE OF HIGH BIAS ON D-BIL NEONATAL PATIENT SAMPLES IS UNKNOWN. SIEMENS IS INVESTIGATING THIS ISSUE.

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR 2432235-2013-00074 WAS FILED ON MARCH 4, 2013. ADDITIONAL INFORMATION (07/29/2013): A SIEMENS GLOBAL PRODUCT SUPPORT SPECIALIST (GPS) CONTACTED THE CUSTOMER SITE. THE CUSTOMER STATED THAT THEY WERE NOT USING THE CALIBRATOR AS PER THE INSTRUCTIONS FOR USE (IFU), AND SINCE CORRECTING THIS ISSUE THE RESULTS ARE WITHIN ACCEPTABLE RANGE AND SPECIFICATIONS. THE SYSTEM IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    HIGH BIAS WAS OBSERVED ON MULTIPLE NEONATAL PATIENT SAMPLES FOR DIRECT BILIRUBIN (D-BIL) ON AN ADVIA 1800 INSTRUMENT. IT IS UNKNOWN IF ANY DISCORDANT PATIENT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE WERE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE HIGH BIAS ON D-BIL RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92361 ADVIA 1800 CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 1800

    Patients

    Seq Age Sex Outcome Treatment
    1