BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2432235-2016-00095

    MDR report key: 5463527 · Received February 26, 2016

    Report

    Report Number
    2432235-2016-00095
    Event Type
    Malfunction
    Date Received
    February 26, 2016
    Date of Event
    February 8, 2016
    Report Date
    June 17, 2016
    PMA / PMN Number
    K051693
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS INC. (SIEMENS) FILED THE INITIAL MDR (2432235-2016-00095) ON FEBRUARY 26, 2016. JUNE 6, 2016, ADDITIONAL INFORMATION: SIEMENS CONCLUDED THEIR INVESTIGATION INTO THE CAUSE OF THE TWO BLOOD FILM SLIDES BEING MISLABELED ON THE ADVIA AUTOSLIDE SYSTEM AND COULD NOT CONFIRM THE COMPLAINT. THE CUSTOMER COULD NOT PROVIDE THE GLASS SLIDES THAT WERE PRODUCED BY THE ADVIA AUTOSLIDE SYSTEM NOR COULD THEY PROVIDE THE NECESSARY LOG FILES FOR THE INVESTIGATION. A SIEMENS' FIELD SERVICE ENGINEER VISITED THE CUSTOMER SITE AND DID NOT FIND ANY ISSUES WITH THE ADVIA AUTOSLIDE SYSTEM. THE CAUSE OF THE TWO BLOOD FILM SLIDES BEING MISLABELED ON THE ADVIA AUTOSLIDE SYSTEM IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS INC.'S INVESTIGATION DETERMINED THAT THE ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER INSTRUMENT DID PRODUCE AN ERROR MESSAGE IMMEDIATELY PRIOR TO THE CREATION OF THE BLOOD FILM SLIDES BY THE ADVIA AUTOSLIDE SYSTEM. SIEMENS HEALTHCARE DIAGNOSTICS INC. IS INVESTIGATING THE CAUSE OF THE TWO BLOOD FILM SLIDES BEING MISLABELED ON THE ADVIA AUTOSLIDE SYSTEM.

    Description of Event or Problem · 1

    TWO BLOOD FILM SLIDES WERE MISLABELED WHEN CREATED ON THE ADVIA AUTOSLIDE SYSTEM. THE MORPHOLOGY CHARACTERISTICS OF THE BLOOD FILM SLIDES LABELED WITH SAMPLE IDENTIFICATION (SID) NUMBERS (B)(6) DID NOT MATCH THE RESPECTIVE COMPLETE BLOOD COUNTS (CBC) PRODUCED BY THE ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER INSTRUMENT. THE MORPHOLOGY CHARACTERISTICS OF THE BLOOD FILM SLIDE SID (B)(6) MATCHED THE CBC FOR SID (B)(6) AND THE MORPHOLOGY CHARACTERISTICS OF SID (B)(6) MATCHED THE CBC FOR SID (B)(6). NO ERRONEOUS RESULTS WERE RELEASED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE MISLABELED SLIDES PRODUCED BY THE ADVIA AUTOSLIDE SYSTEM.

    Patients

    Seq Age Sex Outcome Treatment
    1