BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA AUTOSLIDE SYSTEM

    MDR report key: 3916650 · Received July 7, 2014

    Report

    Report Number
    2432235-2014-00410
    Event Type
    Malfunction
    Date Received
    July 7, 2014
    Date of Event
    May 28, 2014
    Report Date
    June 12, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    KPA
    PMA / PMN Number
    K051693
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS INC. FILED THE INITIAL MDR (2432235-2014-00410) ON JULY 7, 2014. JULY 21, 2014 - ADDITIONAL INFORMATION: SIEMENS HEALTHCARE DIAGNOSTICS INC. (SIEMENS) COMPLETED THEIR INVESTIGATION INTO THE REPORTED TWO SAMPLE IDENTIFICATION NUMBERS ON ONE GLASS SLIDE BY THE ADVIA AUTOSLIDE SYSTEM. SIEMENS RECEIVED THE GLASS SLIDE FROM THE CUSTOMER AND CONFIRMED THAT IT WAS TWO DIFFERENT OVERLAPPING SAMPLE IDENTIFICATION NUMBERS ON THE ONE GLASS SLIDE. THE CAUSE OF THE EVENT IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS INC IS INVESTIGATING THE REPORTED TWO SAMPLE IDENTIFICATION NUMBERS ON ONE SLIDE BY THE ADVIA AUTOSLIDE SYSTEM. THE CAUSE OF THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED SIEMENS HEALTHCARE DIAGNOSTICS AND REPORTED THAT THE ADVIA AUTOSLIDE SYSTEM PRODUCED A SLIDE WITH TWO SAMPLE IDENTIFICATION NUMBERS. THE SLIDE RESULTS WERE NOT REPORTED TO A PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE REPORTED SLIDE HAVING TWO SAMPLE IDENTIFICATION NUMBERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394327 ADVIA AUTOSLIDE SYSTEM ADVIA AUTOSLIDE SYSTEM KPA SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA AUTOSLIDE SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1