BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 1800

    MDR report key: 3890167 · Received June 24, 2014

    Report

    Report Number
    2432235-2014-00389
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    April 16, 2014
    Report Date
    May 29, 2014
    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
    SF
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SIEMENS CUSTOMER CARE CENTER (CCC) WAS CONTACTED BY THE CUSTOMER. THE CCC DETERMINED THAT THE CUSTOMER WAS GIVEN PROPHYLAXIS, AS A PREVENTATIVE FOR INFECTION AFTER THE ISE STANDARD SERUM EYE SPLASH. THERE IS NO BIOLOGICAL MATERIAL CONTAINED WITHIN THE ISE STANDARD SERUM, WHICH THE CUSTOMER WAS NOT AWARE OF DURING THE EVENT. THE CAUSE OF THE ISE STANDARD SERUM EYE SPLASH IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN EYE SPLASH INCIDENT WHEN DISPOSING ION SELECTIVE ELECTRODE (ISE) STANDARD SERUM ON AN ADVIA 1800 INSTRUMENT. THE CUSTOMER WAS NOT INJURED. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ISE STANDARD SERUM EYE SPLASH INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368168 ADVIA 1800 CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 1800

    Patients

    Seq Age Sex Outcome Treatment
    1